ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System

Atherosclerosis Clinical Trial

Official title:

A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System for the Treatment of Subjects With Symptomatic Claudication From Occlusive Vascular Disease of the Superficial Femoral (SFA) or Common or External Iliac Arteries.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468974
• Other study ID #: 11-113
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: December 2015

Study information

• Verified date: February 2018
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Subject is = 18 and = 80 years of age at the time of signing informed consent.

2. Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 1-3).

For subjects with bilateral lesions, the higher Rutherford-Becker Clinical Category limb will be considered the target extremity to be treated in this trial.

If both limbs are of the same Rutherford Becker Clinical Category, the target extremity will be selected based on investigator discretion.

3. Subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and is able to provide informed consent.

4. Subject agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.

5. Female subject of childbearing potential must: have had a negative pregnancy test within 14 days before treatment; not be nursing at the time of the study procedure and agree at time of consent to use birth control during participation in this trial.

6. Subject has life expectancy > 12 months.

7. Subject is able to take clopidogrel or prasugrel (or ticlopidine, if the subject cannot take clopidogrel or prasugrel) and acetylsalicylic acid (aspirin).

8. Subject must agree not to participate in any other clinical investigation for a period of 12 months following the index procedure. This includes clinical trials of medications and invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.

Angiographic Inclusion Criteria

1. A single de novo native disease segment of the superficial femoral (SFA) or common or external iliac arteries of the target extremity located within the following anatomical parameters:

Iliac

• Proximal margin of target lesion is = 2.5 cm distal to the aortic bifurcation in common iliac artery

• Distal margin of target lesion is = 1.5 cm proximal to the location of inguinal ligament

SFA

• Proximal margin of target lesion is = 1 cm distal to the common femoral artery bifurcation

• Distal margin of target lesion is = 25 cm distal to the common femoral artery bifurcation

2. Vessel diameter from = 5.5 mm to = 6.5 mm evaluated by on-line quantitative vascular angiography (QVA) after pre-dilatation per core laboratory guidelines

3. Target lesion is = 50% DS

4. Target lesion length = 50 mm

5. Patent inflow artery free from significant lesion (= 50% DS and < 100% DS) as confirmed by angiography (treatment of the target lesion acceptable after successful treatment of inflow artery lesion)

6. Patent popliteal artery free from significant lesion (= 50% DS) with at least one patent distal outflow artery (anterior tibial, posterior tibial, or peroneal) that provides in-line circulation to the lower leg and foot, as confirmed by angiography

Exclusion Criteria:

1. A platelet count <100,000 cells/mm3 or >700,000 cells/mm3; a white blood cell count (WBC) <3,000 cells/mm3; or hemoglobin < 10.0 g/dL

2. Acute or chronic renal dysfunction (creatinine > 2.5 mg/dl or >176µmol/L)

3. Severe liver impairment as defined by total bilirubin = 3 mg/dl or two times increase over the normal level of serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT).

4. Known allergies to the following: aspirin, clopidogrel, prasugrel or ticlopidine, heparin, contrast agent (that cannot be adequately premedicated), or drugs similar to everolimus (i.e. tacrolimus, sirolimus, zotarolimus) or other macrolides.

5. Subject requires planned procedure that would necessitate the discontinuation of clopidogrel, prasugrel or ticlopidine.

6. Subject has had or will require treatment with drug eluting stent (DES) or drug coated balloon (DCB) within 6 months pre- or post-index procedure.

7. Subject is unable to walk.

8. Subject has undergone any non-iliac percutaneous intervention, e.g. coronary, carotid, < 30 days prior to the planned index procedure.

9. Subject has received, or is on the waiting list for, a organ transplant.

10. Subject is on chronic hemodialysis.

11. Subject has uncontrolled diabetes mellitus (DM) (HbA1c = 7.0%).

12. Subject has had a myocardial infarction (MI) within the previous 30 days of the planned index procedure.

13. Subject has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limits the subject's ability to walk.

14. Subject has unstable angina defined as rest angina with ECG changes.

15. Subject has a groin infection, or an acute systemic infection that has not been treated successfully or is currently under treatment.

16. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.

17. Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation or is associated with limited life-expectancy, i.e., less than 12 months.

18. Subject is currently participating in an investigational drug, biologic, or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.)

19. Subject is unable to understand or unwilling to cooperate with study procedures.

20. Subject requires general anesthesia for the procedure.

21. Subject has ischemic or neuropathic ulcers on either foot.

22. Subject has prior minor or major amputation of either lower extremity.

23. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria

1. Contralateral lesion distal to the location of inguinal ligament that requires treatment within 30 days before or after the procedure. (Contralateral iliac artery lesions may be treated during the procedure if necessary for contralateral approach to the target lesion).

2. Target extremity has an angiographically significant (> 50% DS) lesion located distal to the target lesion.

3. Acute ischemia of the target extremity

4. Target extremity has been previously treated with any of the following: surgical bypass or endarterectomy.

5. Target vessel has been previously treated with any of the following: stent, laser, atherectomy, surgical bypass, or endarterectomy.

6. Total occlusion (100% DS) of the ipsilateral inflow artery.

7. Angiographic evidence of thrombus in target vessel.

8. The target lesion requires treatment with a device other than percutaneous transluminal angioplasty (PTA) (e.g. but not limited to, directional atherectomy, excimer laser, rotational atherectomy, brachytherapy, cryoplasty, etc.)

9. Target lesion is within or adjacent to an aneurysm.

10. Subject has angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion, or from crossing or pre-dilating the target lesion.

11. Target lesion has moderate-to-severe calcification with either of the following characteristics:

• Circumferential orientation

• Thickness > 2 mm in either radial or longitudinal direction

12. Subject has an abdominal aortic aneurysm > 3 cm or history of aortic revascularization.

Related Conditions & MeSH terms

• Atherosclerosis
• Claudication
• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• ESPRIT BVS
Subjects receiving ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna
Belgium	Abbott Vascular International BVBA	Brussels
Belgium	Sint-Blasius Hospital	Dendermonde
Belgium	Oost Limburg Ziekenhuis	Genk
Belgium	Gent University Hospital	Gent
France	Clinique Pasteur	Toulouse
Germany	Herzzentrum Bad Krozingen	Bad Krozingen
Germany	Park-Krankenhaus Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Success	Study device success is defined on a per device basis, the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.	On Day 0 (From start of index procedure to end of index procedure)
Primary	Technical Success	Technical success is defined on a per lesion basis, the attainment of a final residual stenosis of < 30% at the intended target lesion(s). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as technical success only if the above criteria are met.	On Day 0 (From start of index procedure to end of index procedure)
Primary	Clinical Success	Defined on a per subject basis, as the attainment of a final residual stenosis of < 30% using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications* within 2 days after the index procedure or at hospital discharge, whichever is sooner. (Note that in the ESPRIT I study, only a single target lesion per subject is permitted to be treated).; *Includes the following: Death; Amputation; Scaffold Thrombosis; Target Lesion Revascularization (by any percutaneous or surgical means); Target Vessel Revascularization (by any percutaneous or surgical means).	> or = 2 days after the index procedure
Secondary	Number of Participants With Death	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.); -Non-cardiac death is defined as a death not due to cardiac causes (as defined above).	1 month
Secondary	Number of Participants With Death	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.); -Non-cardiac death is defined as a death not due to cardiac causes (as defined above).	6 months
Secondary	Number of Participants With Death	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.); -Non-cardiac death is defined as a death not due to cardiac causes (as defined above).	1 year
Secondary	Number of Participants With Death	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.); -Non-cardiac death is defined as a death not due to cardiac causes (as defined above).	2 years
Secondary	Number of Participants With Death	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.); -Non-cardiac death is defined as a death not due to cardiac causes (as defined above).	3 years
Secondary	Number of Participants With Any Amputation of Treated Limb (Minor and Major)	The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.; A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.	1 month
Secondary	Number of Participants With Any Amputation of Treated Limb (Minor and Major)	The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.; A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.	6 months
Secondary	Number of Participants With Any Amputation of Treated Limb (Minor and Major)	The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.; A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.	1 year
Secondary	Number of Participants With Any Amputation of Treated Limb (Minor and Major)	The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.; A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.	2 years
Secondary	Number of Participants With Any Amputation of Treated Limb (Minor and Major)	The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.; A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.	3 years
Secondary	Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity	Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.; A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.	0 to 30 days
Secondary	Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity	Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.; A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.	0 to 180 days
Secondary	Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity	Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.; A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.	0 to 365 days
Secondary	Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity	Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.; A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.	0 to 730 days
Secondary	Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity	Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.; A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.	0 to 1095 days
Secondary	Number of Participants With Scaffold Thrombosis	Scaffold Thrombosis is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs within 30 days post- index procedure.	0 to 1 month
Secondary	Scaffold Occlusion	Number of participants with Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure.	1 month
Secondary	Number of Participants With Scaffold Occlusion	Scaffold Thrombosis is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs within 30 days post- index procedure.	6 months
Secondary	Number of Participants With Scaffold Occlusion	Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure.	1 year
Secondary	Number of Participants With Scaffold Occlusion	Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure.	2 years
Secondary	Number of Participants With Scaffold Occlusion	Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure.	0 to 3 years
Secondary	Number of Participants With Target Lesion Revascularization (TLR)	Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.	1 month
Secondary	Number of Participants With Target Lesion Revascularization (TLR)	Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.	6 months
Secondary	Number of Participants With Target Lesion Revascularization (TLR)	Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.	1 year
Secondary	Number of Participants With Target Lesion Revascularization (TLR)	Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.	2 years
Secondary	Number of Participants With Target Lesion Revascularization (TLR)	Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.	3 years
Secondary	Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)	A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis = 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.	1 month
Secondary	Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)	A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis = 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.	6 months
Secondary	Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)	A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis = 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.	1 year
Secondary	Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)	A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis = 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.	2 years
Secondary	Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)	A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis = 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.	3 years
Secondary	Number of Participants With Ipsilateral Extremity Revascularization (IER)	Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity.; Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.	1 month
Secondary	Number of Participants With Ipsilateral Extremity Revascularization (IER)	Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity.; Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.	6 months
Secondary	Number of Participants With Ipsilateral Extremity Revascularization (IER)	Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity.; Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.	1 year
Secondary	Number of Participants With Ipsilateral Extremity Revascularization (IER)	Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity.; Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.	2 years
Secondary	Number of Participants With Ipsilateral Extremity Revascularization (IER)	Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity.; Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.	3 years
Secondary	Number of Participants With Primary Patency	At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.	1 month
Secondary	Number of Participants With Primary Patency	At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.	6 months
Secondary	Number of Participants With Primary Patency	At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.	1 year
Secondary	Number of Participants With Primary Patency	At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.	2 years
Secondary	Number of Participants With Primary Patency	At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.	3 years
Secondary	Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb	The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.; Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable	1 month
Secondary	Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb	The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.; Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable	6 months
Secondary	Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb	The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.; Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable	1 year
Secondary	Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb	The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.; Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable	2 years
Secondary	Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb	The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.; Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable	3 years
Secondary	Ankle Brachial Index (ABI) for the Treated Limb	The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.; An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.; Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)	At 1 month
Secondary	Ankle Brachial Index (ABI) for the Treated Limb	The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.; An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.; Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)	At 6 months
Secondary	Ankle Brachial Index (ABI) for the Treated Limb	The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.; An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.; Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)	At 1 year
Secondary	Ankle Brachial Index (ABI) for the Treated Limb	The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.; An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.; Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)	At 2 years
Secondary	Ankle Brachial Index (ABI) for the Treated Limb	The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.; An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.; Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)	At 3 years
Secondary	Walking Impairment Questionnaire (WIQ) Scores	Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication.; The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).	At 1 month
Secondary	Walking Impairment Questionaire Scores	Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).	At 6 months
Secondary	Walking Impairment Questionaire Scores	Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).	At 1 year
Secondary	Walking Impairment Questionaire Scores	Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).	At 2 years
Secondary	Walking Impairment Questionaire Scores	Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).	At 3 years
Secondary	In-scaffold Peak Systolic Velocity (PSV)	In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound	1 month
Secondary	In-scaffold Peak Systolic Velocity (PSV)	In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound	6 months
Secondary	In-scaffold Peak Systolic Velocity (PSV)	In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound	1 year
Secondary	In-scaffold Peak Systolic Velocity (PSV)	In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound	2 years
Secondary	In-scaffold Peak Systolic Velocity (PSV)	In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound	3 years
Secondary	In-scaffold Peak Systolic Velocity Ratio (PSVR)	In-scaffold Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound	1 month
Secondary	In-scaffold Peak Systolic Velocity Ratio (PSVR)	Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound	6 months
Secondary	In-scaffold Peak Systolic Velocity Ratio (PSVR)	Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound	1 year
Secondary	In-Scaffold Peak Systolic Velocity Ratio (PSVR)	Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound	2 years
Secondary	In-scaffold Peak Systolic Velocity Ratio (PSVR)	Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound	3 years
Secondary	Treated Site Percent Diameter Stenosis (%DS)	Percent diameter stenosis (%DS) value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QA.; Reference Vessel Diameter (RVD); Minimum Luminal Diameter(MLD)	post-procedure
Secondary	Treated Site Percent Diameter Stenosis (%DS)	Percent diameter stenosis (%DS) value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QA.; Reference Vessel Diameter (RVD); Minimum Luminal Diameter(MLD)	12 months
Secondary	Treated Site Late Loss	Mean in-lesion Late Loss is calculated as: (MLD post-procedure - MLD follow-up).; The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, treated site or treated segment. Minimum Lumen Vessel Diameter (MLD) is visually estimated during angiography by the Investigator; it is measured during qualitative comparative analysis (QCA) by the Angiographic Core Lab.	12 months
Secondary	Binary Restenosis (=50% DS)	Binary restenosis is defined as the presence of a hemodynamically significant stenosis = 50% as determined by duplex ultrasound or quantitative angiography (QA).; Scaffold Stenosis = 50% by Duplex Ultrasound Only; In-scaffold %DS = 50% by Arteriogram Only	1 year
Secondary	Quality of Life Measures: Physical Functioning (PF) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 month
Secondary	Quality of Life Measures: Physical Functioning (PF) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 6 months
Secondary	Quality of Life Measures: Physical Functioning (PF) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 year
Secondary	Quality of Life Measures: Physical Functioning (PF) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 2 years
Secondary	Quality of Life Measures: Physical Functioning (PF) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 3 years
Secondary	Quality of Life Measures: Role Physical (RP) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 month
Secondary	Quality of Life Measures: Role Physical (RP) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 6 months
Secondary	Quality of Life Measures: Role Physical (RP) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 year
Secondary	Quality of Life Measures: Role Physical (RP) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 2 years
Secondary	Quality of Life Measures: Role Physical (RP) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 3 years
Secondary	Quality of Life Measures: Bodily Pain (BP) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 month
Secondary	Quality of Life Measures: Bodily Pain (BP) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 6 months
Secondary	Quality of Life Measures: Bodily Pain (BP) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 year
Secondary	Quality of Life Measures: Bodily Pain (BP) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 2 years
Secondary	Quality of Life Measures: Bodily Pain (BP) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 3 years
Secondary	Quality of Life Measures: General Health (GH) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 month
Secondary	Quality of Life Measures: General Health (GH) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 6 months
Secondary	Quality of Life Measures: General Health (GH) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 year
Secondary	Quality of Life Measures: General Health (GH) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 2 years
Secondary	Quality of Life Measures: General Health (GH) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 3 years
Secondary	Quality of Life Measures: Vitality (VT) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 month
Secondary	Quality of Life Measures: Vitality (VT) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 6 months
Secondary	Quality of Life Measures: Vitality (VT) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 year
Secondary	Quality of Life Measures: Vitality (VT) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 2 years
Secondary	Quality of Life Measures: Vitality (VT) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 3 years
Secondary	Quality of Life Measures: Social Functioning (SF) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 month
Secondary	Quality of Life Measures: Social Functioning (SF) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 6 months
Secondary	Quality of Life Measures: Social Functioning (SF) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 year
Secondary	Quality of Life Measures: Social Functioning (SF) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 2 years
Secondary	Quality of Life Measures: Social Functioning (SF) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 3 years
Secondary	Quality of Life Measures: Role Emotional (RE) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 month
Secondary	Quality of Life Measures: Role Emotional (RE) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 6 months
Secondary	Quality of Life Measures: Role Emotional (RE) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 year
Secondary	Quality of Life Measures: Role Emotional (RE) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 2 years
Secondary	Quality of Life Measures: Role Emotional (RE) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 3 years
Secondary	Quality of Life Measures: Mental Health (MH) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 month
Secondary	Quality of Life Measures: Mental Health (MH) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 6 months
Secondary	Quality of Life Measures: Mental Health (MH) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 year
Secondary	Quality of Life Measures: Mental Health (MH) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 2 years
Secondary	Quality of Life Measures: Mental Health (MH) Summary	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 3 years
Secondary	Quality of Life Measures: Physical Component Summary (PCS)	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 month
Secondary	Quality of Life Measures: Physical Component Summary (PCS)	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 6 months
Secondary	Quality of Life Measures: Physical Component Summary (PCS)	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 year
Secondary	Quality of Life Measures: Physical Component Summary (PCS)	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 2 years
Secondary	Quality of Life Measures: Mental Component Summary (MCS)	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 month
Secondary	Quality of Life Measures: Physical Component Summary (PCS)	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 3 years
Secondary	Quality of Life Measures: Mental Component Summary (MCS)	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 6 months
Secondary	Quality of Life Measures: Mental Component Summary (MCS)	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 1 year
Secondary	Quality of Life Measures: Mental Component Summary (MCS)	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 2 years
Secondary	Quality of Life Measures: Mental Component Summary (MCS)	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.	At 3 years
Secondary	Vascular Quality of Life (VascuQol) Scores Summary	Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.; The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain.	At 1 month
Secondary	Vascular Quality of Life (VascuQol) Scores Summary	Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.; The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain.	At 6 months
Secondary	Vascular Quality of Life (VascuQol) Scores Summary	Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.; The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain.	At 1 year
Secondary	Vascular Quality of Life (VascuQol) Scores Summary	Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.; The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain.	At 2 years
Secondary	Vascular Quality of Life (VascuQol) Scores Summary	Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.; The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain.	At 3 years