The ABSORB BTK (Below The Knee) Clinical Investigation

Atherosclerosis Clinical Trial

Official title:

A Clinical Evaluation of the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS) for the Treatment of Subjects With Critical Limb Ischemia (CLI) From Occlusive Vascular Disease of the Tibial Arteries

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01341340
• Other study ID #: 10-112
• Status: Terminated
• Phase: N/A
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: April 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the ABSORB BTK Clinical Investigation is to evaluate the safety and efficacy of the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS) in subjects with critical limb ischemia (CLI) following percutaneous transluminal angioplasty (PTA) of the tibial arteries.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Subject must be at least 18 and = 80 years of age.

2. History of symptomatic critical limb ischemia (CLI) (Rutherford Becker Clinical Category 4 or 5).

3. Subject is able to take at least one type of thienopyridine (e.g. clopidogrel) and acetylsalicylic acid (eg. Aspirin/ASA).

4. The subject must have a life-expectancy of more than 1 year.

5. Female subjects of childbearing potential must have had a negative pregnancy test within 14 days before treatment, must not be nursing at the time of treatment, and must also agree at time of consent to use birth control during participation in this study up to and including the angiographic follow-up at 1 year.

6. Subject has been informed of the nature of the study, agrees to its provisions, and has signed the informed consent form prior to any study related procedure.

7. Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site.

8. Subject must agree not to participate in any other clinical investigation for a period of one year 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.

Anatomic Inclusion Criteria

1. Up to two de novo lesions, each located in a separate native infrapopliteal vessel, with angiographically visible above-the-ankle reconstitution (proximal to the inferior cortical margin of the talus bone), only one of which can be designated as the target lesion and is suitable to be treated with a single BVS.

2. Target lesion length is visually estimated to be = 24 mm.

3. Target vessel diameter at the location of the target lesion is = 2.5 mm and = 3.3 mm, as assessed by on-line quantitative angiography as per core laboratory guidelines.

4. The non-target lesion (if applicable) must be located in a separate infrapopliteal vessel, estimated to be = 24 mm, and suitable to be treated with non-study percutaneous transluminal angioplasty (PTA) balloon(s) and/or a non-study stent.

5. Inflow between the proximal iliac and distal popliteal is unobstructed (free from = 50% stenosis) as confirmed by angiography. [Note: Assessment may be made after interventions proximal to the target lesion.]

6. Subjects with a significant lesion (= 50% stenosis) in the inflow artery(ies) must have the inflow artery(ies) treated successfully prior to enrollment and treatment of the target lesion.

7. If there is evidence of an ischemic lesion/ulcer on the foot, the distribution of the target vessel must supply the area of the lesion (angiosome), as confirmed by angiography.

8. At least one patent distal tibial outflow artery (< 50% stenosis) that will provide a straight line of blood flow to the distal foot and (if applicable) wound area after treating a target lesion in the tibio-peroneal trunk.

9. Patent pedal outflow artery (< 50% stenosis) that will provide a straight line of blood flow to the distal foot and (if applicable) wound area.

Exclusion Criteria:

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

2. The subject is mentally ill or belongs to a vulnerable population.

3. Subject is currently breast-feeding, pregnant, or intends to become pregnant prior to completion of the 1 year angiographic follow-up.

4. Subject has had any type of amputation to the ipsilateral or contralateral extremity.

5. Subject is unable to walk. (with assistance is accepted)

6. Subject has had recent major surgery (requiring general or regional anesthesia or impacting major organ systems) within the last 3 months.

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

8. Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 2, 3 or 6.

9. Subject has any type of infection, until treated successfully.

10. Subject has osteomyelitis present in the distal ipsilateral extremity.

11. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.

12. The subject has a history of prior life-threatening contrast media reaction.

13. Subject is receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the procedure.

14. Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.).

15. Subject is receiving or will receive inhibitors of CYP3A or inducers of CYP3A within 30 days prior to or following the procedure.

16. Subject is receiving Phenprocoumon (Marcumar) or is scheduled to receive chronic anticoagulation therapy.

17. Subject has severe liver impairment as defined by total bilirubin > 3 mg/dl or two times increase over the normal level of serum glutamic oxaloacetic transminase(SGOT) or serum glutamic pyruvic transminase (SGPT).

18. Subject has platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC < 3,000 cells/mm3, or hemoglobin < 10.0 g/dl.

19. Subject has elevated serum creatinine > 2.0 mg/dl or > 150µmol/L.

20. Subject has uncontrolled diabetes mellitus (DM) (glucose > 400 mg/dl).

21. Subject has had a myocardial infarction (MI) within the previous 30 days or has unstable angina (defined as rest angina with ECG changes).

22. Subject has had a stroke within the previous 30 days and/or has deficits from a prior stroke that limits the subject's mobility.

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

24. Subject has known allergies to the following: aspirin, thienopyridines, heparin, contrast agent (that cannot be adequately treated with pre-medication or substitution for an alternate thienopyridine), poly (L-lactide), poly (DL-lactide), or drugs similar to everolimus (i.e. tacrolimus, sirolimus, zotarolimus), or other macrolides.

25. Subject requires any planned procedure that would necessitate the discontinuation of thienopyridines following the procedure. If the subject is enrolled into the study and then requires a medical procedure, which would necessitate the discontinuation of these medications, then the subject is to resume protocol recommended medications as soon as possible.

26. Subject has other known 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 1 year).

27. Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.

Anatomic Exclusion Criteria

1. The target lesion can only be accessed via popliteal or pedal approach.

2. The target vessel diameter at the location of the target lesion is not suitable for available BVS size.

3. Unsuccessfully treated proximal inflow limiting arterial stenosis or inflow-limiting arterial lesions left untreated.

4. No angiographic evidence of a patent pedal artery.

5. Significant (> 50% stenosis) lesion in a distal outflow artery that requires treatment at the time of the index procedure.

6. More than a single significant lesion (> 50% stenosis) in the target vessel.

7. Target or (if applicable) non-target lesion location requiring bifurcation treatment method.

8. Target or (if applicable) non-target lesion lies within or adjacent to an aneurysm.

9. A segment/portion of the study scaffold will be deployed distal to the inferior cortical margin of the talus bone or in a pedal vessel.

10. Subject has previously had, or requires, bypass surgery, endarterectomy or other vascular surgery on any vessel of the ipsilateral extremity.

11. Subject has moderate to severe calcium in the target lesion or in the artery immediately adjacent to the target lesion, or the investigator is unable to pre-dilate the lesion according to vessel diameter.

12. Target or (if applicable) non-target vessel contains visible thrombus as indicated in the angiographic images.

13. Subject has angiographic evidence of thromboembolism or atheroembolism in the ipsilateral extremity. (Pre and post-angiographic images must confirm the absence of emboli in the distal anatomy.)

14. Target or (if applicable) non-target lesion has a high probability that a procedure other than pre-dilatation, implantation of the scaffold, and post-dilatation (as applicable) will be required at the time of index procedure for treatment of the target vessel (e.g., atherectomy, cutting balloon, etc.).

15. Subject has lesions in the target vessel that were treated or will require treatment < 1 year pre-or post- study procedure.

16. Subject has lesions in any other vascular anatomy, other than those treated at the time of the study procedure, that were treated or will require treatment < 30 days pre-or post- study procedure.

17. Subject has had or will require treatment with a drug-eluting/coated stent or drugcoated balloon in any vessel < 90 days pre-or post-study procedure.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Atherosclerosis
• Claudication
• Critical Limb Ischemia
• Intermittent Claudication
• Ischemia
• Lower Limb Disease
• PAD
• PAOD
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease
• Peripheral Artery Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• PVD
• Vascular Diseases

Intervention

Device:
• Everolimus Eluting BVS
Patients receiving the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS)

Locations

Country	Name	City	State
Belgium	Abbott Vascular International Bvba	Diegem

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from major adverse limb events (MALE) within 1 year or peri-procedural (30-day) death (POD) (MALE+POD).	Major adverse limb events are defined as major amputations or major reinterventions. Major reinterventions include new bypass graft, jump/interposition graft revision, or thrombectomy /thrombolysis related to the target lesion, but do not include percutaneous endovascular reinterventions.	1 year
Secondary	Device Success	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.	From start of index procedure to end of index procedure
Secondary	Technical Success	Defined on a per lesion basis, as the achievement of successful delivery and deployment of the study device(s) at the intended target lesion, successful withdrawal of the delivery catheter, and attainment of a final residual stenosis of < 30%.	From start of index procedure to end of index procedure
Secondary	Clinical Success	On a per subject basis, technical success without complications within 48 hours after the index procedure or at hospital discharge, whichever is sooner.	Within 48 hours after the index procedure or at hospital discharge, whichever is sooner
Secondary	Death	all cause	From start of procedure until discharge from treating or referral hospital
Secondary	Death	all cause.	1 month
Secondary	Death	all cause.	6 months
Secondary	Death	all cause.	1 year
Secondary	Death	all cause.	2 years
Secondary	Death	all cause.	3 years
Secondary	Amputations	minor and major	From start of procedure until discharge from treating or referral hospital
Secondary	Amputations	minor and major	1 month
Secondary	Amputations	minor and major	6 months
Secondary	Amputations	minor and major	1 year
Secondary	Amputations	minor and major	2 years
Secondary	Amputations	minor and major	3 years
Secondary	Limb Salvage	Freedom from ipsilateral major amputations	From start of procedure until discharge from treating or referral hospital
Secondary	Limb Salvage	Freedom from ipsilateral major amputations	1 month
Secondary	Limb Salvage	Freedom from ipsilateral major amputations	6 months
Secondary	Limb Salvage	Freedom from ipsilateral major amputations	1 year
Secondary	Limb Salvage	Freedom from ipsilateral major amputations	2 years
Secondary	Limb Salvage	Freedom from ipsilateral major amputations	3 years
Secondary	Arterial thrombosis of the BVS		From start of procedure until discharge from treating or referral hospital
Secondary	Arterial thrombosis of the BVS		1 month
Secondary	Arterial thrombosis of the BVS		6 months
Secondary	Arterial thrombosis of the BVS		1 year
Secondary	Arterial thrombosis of the BVS		2 years
Secondary	Arterial thrombosis of the BVS		3 years
Secondary	Amputation-free survival (AFS)		From start of procedure until discharge from treating or referral hospital
Secondary	Amputation-free survival (AFS)		1 month
Secondary	Amputation-free survival (AFS)		6 months
Secondary	Amputation-free survival (AFS)		1 year
Secondary	Amputation-free survival (AFS)		2 years
Secondary	Amputation-free survival (AFS)		3 years
Secondary	Ipsilateral embolic events		From start of procedure until discharge from treating or referral hospital
Secondary	Ipsilateral embolic events		1 month
Secondary	Ipsilateral embolic events		6 months
Secondary	Ipsilateral embolic events		1 year
Secondary	Ipsilateral embolic events		2 years
Secondary	Ipsilateral embolic events		3 years
Secondary	Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)		From start of procedure until discharge from treating or referral hospital
Secondary	Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)		1 month
Secondary	Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)		6 months
Secondary	Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)		1 years
Secondary	Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)		2 years
Secondary	Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)		3 years
Secondary	Ipsilateral extremity revascularization (IER)		From start of procedure until discharge from treating or referral hospital
Secondary	Ipsilateral extremity revascularization (IER)		1 month
Secondary	Ipsilateral extremity revascularization (IER)		6 months
Secondary	Ipsilateral extremity revascularization (IER)		1 year
Secondary	Ipsilateral extremity revascularization (IER)		2 years
Secondary	Ipsilateral extremity revascularization (IER)		3 years
Secondary	Peak Systolic Velocity Ratio (PSVR)		From start of procedure until discharge from treating or referral hospital
Secondary	Peak Systolic Velocity Ratio (PSVR)		1 month
Secondary	Peak Systolic Velocity Ratio (PSVR)		6 months
Secondary	Peak Systolic Velocity Ratio (PSVR)		1 year
Secondary	Peak Systolic Velocity Ratio (PSVR)		2 years
Secondary	Peak Systolic Velocity Ratio (PSVR)		3 years
Secondary	Primary patency rate		From start of procedure until discharge from treating or referral hospital
Secondary	Primary patency rate		1 month
Secondary	Primary patency rate		6 months
Secondary	Primary patency rate		1 year
Secondary	Primary patency rate		2 years
Secondary	Primary patency rate		3 years
Secondary	Secondary patency rate		From start of procedure until discharge from treating or referral hospital
Secondary	Secondary patency rate		1 month
Secondary	Secondary patency rate		6 months
Secondary	Secondary patency rate		1 year
Secondary	Secondary patency rate		2 years
Secondary	Secondary patency rate		3 years
Secondary	Rutherford Becker clinical category and change from baseline for the treated limb		From start of procedure until discharge from treating or referral hospital
Secondary	Rutherford Becker clinical category and change from baseline for the treated limb		1 month
Secondary	Rutherford Becker clinical category and change from baseline for the treated limb		6 months
Secondary	Rutherford Becker clinical category and change from baseline for the treated limb		1 year
Secondary	Rutherford Becker clinical category and change from baseline for the treated limb		2 years
Secondary	Rutherford Becker clinical category and change from baseline for the treated limb		3 years
Secondary	Ankle brachial index (ABI) and change from baseline for the treated limb		From start of procedure until discharge from treating or referral hospital
Secondary	Ankle brachial index (ABI) and change from baseline for the treated limb		1 month
Secondary	Ankle brachial index (ABI) and change from baseline for the treated limb		6 months
Secondary	Ankle brachial index (ABI) and change from baseline for the treated limb		1 year
Secondary	Ankle brachial index (ABI) and change from baseline for the treated limb		2 years
Secondary	Ankle brachial index (ABI) and change from baseline for the treated limb		3 years
Secondary	Wound healing as measured by aggregate ulcer size and its change from baseline		From start of procedure until discharge from treating or referral hospital
Secondary	Wound healing as measured by aggregate ulcer size and its change from baseline		1 month
Secondary	Wound healing as measured by aggregate ulcer size and its change from baseline		6 months
Secondary	Wound healing as measured by aggregate ulcer size and its change from baseline		1 year
Secondary	Wound healing as measured by aggregate ulcer size and its change from baseline		2 years
Secondary	Wound healing as measured by aggregate ulcer size and its change from baseline		3 years
Secondary	Walking capacity and change from baseline		From start of procedure until discharge from treating or referral hospital
Secondary	Walking capacity and change from baseline		1 month
Secondary	Walking capacity and change from baseline		6 months
Secondary	Walking capacity and change from baseline		1 year
Secondary	Walking capacity and change from baseline		2 years
Secondary	Walking capacity and change from baseline		3 years
Secondary	Quality of Life Measures and change from baseline		From start of procedure until discharge from treating or referral hospital
Secondary	Quality of Life Measures and change from baseline		1 month
Secondary	Quality of Life Measures and change from baseline		6 months
Secondary	Quality of Life Measures and change from baseline		1 year
Secondary	Quality of Life Measures and change from baseline		2 years
Secondary	Quality of Life Measures and change from baseline		3 years
Secondary	Target lesion mean and maximum treated site percent diameter stenosis (%DS)		1 year
Secondary	Target lesion mean treated site late loss		1 year
Secondary	Target lesion treated site binary restenosis		1 year
Secondary	Treated site Peak Systolic Velocity (PSV)		From start of procedure until discharge from treating or referral hospital
Secondary	Treated site Peak Systolic Velocity (PSV)		1 month
Secondary	Treated site Peak Systolic Velocity (PSV)		6 months
Secondary	Treated site Peak Systolic Velocity (PSV)		1 year
Secondary	Treated site Peak Systolic Velocity (PSV)		2 years
Secondary	Treated site Peak Systolic Velocity (PSV)		3 years