EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries

Iliac Artery Stenosis Clinical Trial

— ORION  

Official title:

A Boston Scientific Trial of the EPIC™ Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896337
• Other study ID #: S2020
• Status: Completed
• Phase: Phase 3
• First received: May 8, 2009
• Last updated: April 17, 2015
• Start date: May 2009
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The ORION study is being conducted to determine whether the Epic™ Nitinol Stent for primary stenting of iliac atherosclerotic lesions shows acceptable performance at 9 months.

Description:

ORION is a prospective, single arm, non-randomized, multicenter study. A subject could receive a maximum of 2 study stents for up to 2 target lesions. A maximum of 1 non-target lesion in 1 non-target vessel could be treated with a commercially approved treatment during the index procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented chronic, symptomatic iliac artery atherosclerotic disease (Rutherford/Becker category 1, 2, 3 or 4)

• Lifestyle-limiting claudication or rest pain

• De novo or restenotic lesions in the common and/or external iliac artery

• Subjects with bilateral disease may have only one target lesion treated per side

• Two target lesions may be treated with a maximum of two stents (if two target lesions are treated, each lesion must be covered with a maximum of one stent)

• Length of diseased segment(s) <=13 cm and treatment is planned with no more than 2 overlapped Epic™ stents

• Baseline diameter stenosis >= 50% (operator visual assessment)

• Reference vessel diameter >= 5 mm and <=11 mm

• At least one sufficient ipsilateral infrapopliteal run-off vessel

• Origin of profunda femoris artery is patent

Exclusion Criteria:

• Target vessel with in-stent restenosis

• Acute critical limb ischemia

• Tissue loss (Rutherford/Becker category 5 or 6)

• Any major amputations to the target limb

• Any minor amputation of the target limb in the last 12 months. If a minor amputation occurred greater than 12 months, stump needs to be completely healed.

• Life expectancy less than 24 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the trial

• Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.

• Intolerance to antiplatelet, anticoagulant, or thrombolytic medications

• Platelet count < 150,000 mm3 or > 600,000 mm3

• Serum creatinine > 2.0 mg/dL

• Dialysis-dependent end stage renal disease

• Pregnancy

• Current participation in another drug or device trial that has not completed the primary endpoint or that may potentially confound the results of this trial

• Known allergy to Nitinol

• Presence of arterial lesions (with the exception of renal, carotid or short, focal SFA lesions) requiring intervention within 30 days of the index procedure - Superficial femoral artery occlusion in the limb supplied by target vessel

• Heavily calcified and/or excessively tortuous lesions in the target vessel as determined by angiography

• Target lesion is within or near an aneurysm

• Persistent, intraluminal thrombus of the proposed target lesion post-thrombolytic therapy

• Perforated vessel as evidenced by extravasation of contrast media

• Vascular graft, aneurysm or postsurgical stenosis of the target vessel

• Multiple lesions in the same target vessel unable to be treated with a maximum of two stents

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Iliac Artery Stenosis

Intervention

Device:
• Epic™ Nitinol Stent System
The Epic™ Nitinol Stent System is comprised of two components: the implantable nitinol endoprosthesis and the stent delivery system.

Drug:
• Anti-platelet therapy
Investigators must prescribe concomitant anti-platelet medication consistent with current clinical practice. Anti-platelet therapy should be administered preprocedure and continued throughout participation in the trial.
• Anti-coagulation therapy
Anti-coagulation therapy must be administered during the procedure consistent with current clinical practice.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Piedmont Hospital	Atlanta	Georgia
United States	Brandon Regional Hospital	Brandon	Florida
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Mid-Carolina Cardiology - Presbyterian Hospital	Charlotte	North Carolina
United States	Erlanger Medical Center	Chattanooga	Tennessee
United States	Cleveland Clinic	Cleveland	Ohio
United States	Grant Medical Center	Columbus	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	VA North Texas Health Care System	Dallas	Texas
United States	Trinity Terrace Park	Davenport	Iowa
United States	MeritCare Hospital	Fargo	North Dakota
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	Parkview Hospital-Parkview Research Center	Fort Wayne	Indiana
United States	St. Vincent's Hospital	Indianapolis	Indiana
United States	Wellstar Kennestone Hospital	Marietta	Georgia
United States	St. Thomas Research Institute	Nashville	Tennessee
United States	Mount Sinai Medical Center	New York	New York
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Mediquest Research at Munroe Regional Medical Center	Ocala	Florida
United States	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma
United States	UPMC - Shadyside Hospital	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Wake Medical Center	Raleigh	North Carolina
United States	North Memorial Medical Center	Robbinsdale	Minnesota
United States	Baptist Hospital of San Antonio	San Antonio	Texas
United States	St. Joseph's Hospital	Tucson	Arizona
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device- and/or Procedure-related Major Adverse Events (MAE)	MAE is defined as any device-related or index procedure-related death within 30 days, myocardial infarction during index hospitalization, target vessel revascularization through 9 months, or amputation of the index limb through 9 months	9 Months	Yes
Secondary	Death	Death is classified as follows. Cardiac death: death due to immediate cardiac cause, death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions	30 Days	Yes
Secondary	Death	Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions	9 Months	Yes
Secondary	Death	Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions	1 Year	Yes
Secondary	Death	Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions	2 Years	Yes
Secondary	Death	Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions	3 Years	Yes
Secondary	Amputation of Index Limb	Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes	9 Months	Yes
Secondary	Amputation of Index Limb	Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes	1 Year	Yes
Secondary	Amputation of Index Limb	Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes	2 Years	Yes
Secondary	Amputation of Index Limb	Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes	3 Years	Yes
Secondary	Target Vessel Revascularization (TVR)	Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is =50% by quantitative angiography and the subject has ischemic symptoms.; A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia.	30 Days	No
Secondary	Target Vessel Revascularization (TVR)	Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is =50% by quantitative angiography and the subject has ischemic symptoms.; A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia.	9 Months	No
Secondary	Target Vessel Revascularization (TVR)	Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is =50% by quantitative angiography and the subject has ischemic symptoms.; A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia.	1 Year	No
Secondary	Target Vessel Revascularization (TVR)	Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is =50% by quantitative angiography and the subject has ischemic symptoms.; A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia.	2 Years	No
Secondary	Target Vessel Revascularization (TVR)	Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is =50% by quantitative angiography and the subject has ischemic symptoms.; A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia.	3 Years	No
Secondary	Myocardial Infarction (MI)	Definition of myocardial infarction: New Q-waves in =2 leads lasting =0.04 sec with creatine kinase- myoglobin band (CK-MB)/troponin above upper limit of normal (ULN); if no new Q-waves elevation of post-procedure CK levels >2.0× ULN with positive CK-MB, or, if the assay for CK-MB was not performed, elevation of CK levels >2.0× ULN with positive troponin. Drawing a CK-MB or troponin is mandated if CK is greater than 2× ULN. If no CK-MB or troponin was drawn, CK >2× ULN will be considered an MI. ULN is determined per local laboratory specifications.	Index hospitalization	Yes
Secondary	Technical Success	Residual lesion stenosis <=30% based on visual assessment immediately postprocedure	Index procedure	No
Secondary	Procedure Success	Technical success (residual lesion stenosis <=30% based on visual assessment immediately postprocedure) and no in-hospital major adverse events (device- or index procedure-related death, myocardial infarction, target vessel revascularization or amputation of the index limb).	In hospital (1-2 days post procedure)	Yes
Secondary	Early Clinical Success	Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema	Hospital Discharge	No
Secondary	Early Clinical Success	Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema	30 Days	No
Secondary	Late Clinical Success	Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema	9 Months	No
Secondary	Late Clinical Success	Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema	1 Year	No
Secondary	Early Hemodynamic Success	Improvement in ankle-brachial index (ABI) by =0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.	Hospital Discharge	No
Secondary	Early Hemodynamic Success	Improvement in ankle-brachial index (ABI) by =0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.	30 Days	No
Secondary	Late Hemodynamic Success	Improvement in ankle-brachial index (ABI) by =0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.	9 Months	No
Secondary	Late Hemodynamic Success	Improvement in ankle-brachial index (ABI) by =0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.	1 Year	No
Secondary	Rutherford Classification Distribution	Rutherford Classification is used to assess lower extremity ischemia as shown below: 0 = Asymptomatic; = Mild claudication; = Moderate claudication; = Severe claudication; = Ischemic rest pain; = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema	Pre-procedure/baseline	No
Secondary	Rutherford Classification Distribution	Rutherford Classification is used to assess lower extremity ischemia as shown below: 0 = Asymptomatic; = Mild claudication; = Moderate claudication; = Severe claudication; = Ischemic rest pain; = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema	Post-procedure	No
Secondary	Rutherford Classification Distribution	Rutherford Classification is used to assess lower extremity ischemia as shown below: 0 = Asymptomatic; = Mild claudication; = Moderate claudication; = Severe claudication; = Ischemic rest pain; = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema	30 Days	No
Secondary	Rutherford Classification Distribution	Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss	9 Months	No
Secondary	Rutherford Classification Distribution	Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss	1 Year	No
Secondary	Acute Stent Thrombosis	Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion; Acute stent thrombosis is defined as occurring <=24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to <=30 days following the trial procedure.	24 Hours	Yes
Secondary	Sub-acute Stent Thrombosis	Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion; Acute stent thrombosis is defined as occurring less than or equal to 24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to less than or equal to 30 days following the trial procedure.	>24 Hours to <=30 Days Post-index procedure	Yes
Secondary	Stent Thrombosis	Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion; Late stent thrombosis is defined as >30 days to 365 days following the trial procedure.	9 Months	Yes
Secondary	Stent Thrombosis	Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion; Late stent thrombosis is defined as >30 days to 365 days following the trial procedure.	1 Year	Yes
Secondary	Stent Thrombosis	Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion; Very late stent thrombosis is defined as >365 days following the trial procedure.	2 Years	Yes
Secondary	Stent Thrombosis	Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion; Very late stent thrombosis is defined as >365 days following the trial procedure.	3 Years	Yes
Secondary	Target Lesion Revascularization (TLR)	Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is =50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia.	30 Days	No
Secondary	Target Lesion Revascularization (TLR)	Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is =50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia.	9 Months	No
Secondary	Target Lesion Revascularization (TLR)	Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is =50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia.	1 Year	No
Secondary	Target Lesion Revascularization (TLR)	Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is =50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia.	2 Years	No
Secondary	Target Lesion Revascularization (TLR)	Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is =50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is =70% even in the absence of clinical or functional ischemia.	3 Years	No
Secondary	Ankle-Brachial Index (ABI)	Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.; Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.	Pre-procedure/baseline	No
Secondary	Ankle-Brachial Index	Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.; Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.	Hospital Discharge (1-2 days post-procedure)	No
Secondary	Ankle-Brachial Index (ABI)	Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.; Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.	30 Days	No
Secondary	Ankle-Brachial Index (ABI)	Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.; Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.	9 Months	No
Secondary	Ankle-Brachial Index (ABI)	Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.; Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.	1 Year	No
Secondary	Primary Patency	Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR =2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.	9 Months	No
Secondary	Primary Patency	Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR =2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.	1 Year	No
Secondary	Primary-assisted Patency (PAP)	Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR =2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.	9 Months	No
Secondary	Primary-assisted Patency (PAP)	Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR =2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.	1 Year	No
Secondary	Secondary Patency	Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR =2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.	9 Months	No
Secondary	Secondary Patency	Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR =2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.	1 Year	No
Secondary	Restenosis Assessed by Duplex Ultrasound	Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.	9 Months	No
Secondary	Restenosis Assessed by Duplex Ultrasound	Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.	1 Year	No
Secondary	Walking Impairment Questionnaire Score - Distance	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	Pre-procedure/baseline	No
Secondary	Walking Impairment Questionnaire Score - Distance	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	9 Months	No
Secondary	Walking Impairment Questionnaire Score - Distance	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	1 Year	No
Secondary	Walking Impairment Questionnaire Score - Speed	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	Pre-procedure/baseline	No
Secondary	Walking Impairment Questionnaire Score - Speed	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	9 Months	No
Secondary	Walking Impairment Questionnaire Score - Speed	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	1 Year	No
Secondary	Walking Impairment Questionnaire Score-Stair Climbing	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	Pre-procedure/baseline	No
Secondary	Walking Impairment Questionnaire Score - Stair Climbing	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	9 Months	No
Secondary	Walking Impairment Questionnaire Score - Stair Climbing	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	1 Year	No