The ABSORB BTK (Below The Knee) Clinical Investigation

April 9, 2019 updated by: Abbott Medical Devices

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Diegem, Belgium
        • Abbott Vascular International BVBA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Everolimus Eluting BVS
Patients receiving the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS)
Patients receiving the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from major adverse limb events (MALE) within 1 year or peri-procedural (30-day) death (POD) (MALE+POD).
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Success
Time Frame: From start of index procedure to end of index procedure
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
Technical Success
Time Frame: From start of index procedure to end of index procedure
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
Clinical Success
Time Frame: Within 48 hours after the index procedure or at hospital discharge, whichever is sooner
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
Death
Time Frame: From start of procedure until discharge from treating or referral hospital
all cause
From start of procedure until discharge from treating or referral hospital
Death
Time Frame: 1 month
all cause.
1 month
Death
Time Frame: 6 months
all cause.
6 months
Death
Time Frame: 1 year
all cause.
1 year
Death
Time Frame: 2 years
all cause.
2 years
Death
Time Frame: 3 years
all cause.
3 years
Amputations
Time Frame: From start of procedure until discharge from treating or referral hospital
minor and major
From start of procedure until discharge from treating or referral hospital
Amputations
Time Frame: 1 month
minor and major
1 month
Amputations
Time Frame: 6 months
minor and major
6 months
Amputations
Time Frame: 1 year
minor and major
1 year
Amputations
Time Frame: 2 years
minor and major
2 years
Amputations
Time Frame: 3 years
minor and major
3 years
Limb Salvage
Time Frame: From start of procedure until discharge from treating or referral hospital
Freedom from ipsilateral major amputations
From start of procedure until discharge from treating or referral hospital
Limb Salvage
Time Frame: 1 month
Freedom from ipsilateral major amputations
1 month
Limb Salvage
Time Frame: 6 months
Freedom from ipsilateral major amputations
6 months
Limb Salvage
Time Frame: 1 year
Freedom from ipsilateral major amputations
1 year
Limb Salvage
Time Frame: 2 years
Freedom from ipsilateral major amputations
2 years
Limb Salvage
Time Frame: 3 years
Freedom from ipsilateral major amputations
3 years
Arterial thrombosis of the BVS
Time Frame: From start of procedure until discharge from treating or referral hospital
From start of procedure until discharge from treating or referral hospital
Arterial thrombosis of the BVS
Time Frame: 1 month
1 month
Arterial thrombosis of the BVS
Time Frame: 6 months
6 months
Arterial thrombosis of the BVS
Time Frame: 1 year
1 year
Arterial thrombosis of the BVS
Time Frame: 2 years
2 years
Arterial thrombosis of the BVS
Time Frame: 3 years
3 years
Amputation-free survival (AFS)
Time Frame: From start of procedure until discharge from treating or referral hospital
From start of procedure until discharge from treating or referral hospital
Amputation-free survival (AFS)
Time Frame: 1 month
1 month
Amputation-free survival (AFS)
Time Frame: 6 months
6 months
Amputation-free survival (AFS)
Time Frame: 1 year
1 year
Amputation-free survival (AFS)
Time Frame: 2 years
2 years
Amputation-free survival (AFS)
Time Frame: 3 years
3 years
Ipsilateral embolic events
Time Frame: From start of procedure until discharge from treating or referral hospital
From start of procedure until discharge from treating or referral hospital
Ipsilateral embolic events
Time Frame: 1 month
1 month
Ipsilateral embolic events
Time Frame: 6 months
6 months
Ipsilateral embolic events
Time Frame: 1 year
1 year
Ipsilateral embolic events
Time Frame: 2 years
2 years
Ipsilateral embolic events
Time Frame: 3 years
3 years
Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)
Time Frame: From start of procedure until discharge from treating or referral hospital
From start of procedure until discharge from treating or referral hospital
Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)
Time Frame: 1 month
1 month
Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)
Time Frame: 6 months
6 months
Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)
Time Frame: 1 years
1 years
Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)
Time Frame: 2 years
2 years
Freedom from target lesion revascularization (TLR)(ischemia driven and non-ischemia driven)
Time Frame: 3 years
3 years
Ipsilateral extremity revascularization (IER)
Time Frame: From start of procedure until discharge from treating or referral hospital
From start of procedure until discharge from treating or referral hospital
Ipsilateral extremity revascularization (IER)
Time Frame: 1 month
1 month
Ipsilateral extremity revascularization (IER)
Time Frame: 6 months
6 months
Ipsilateral extremity revascularization (IER)
Time Frame: 1 year
1 year
Ipsilateral extremity revascularization (IER)
Time Frame: 2 years
2 years
Ipsilateral extremity revascularization (IER)
Time Frame: 3 years
3 years
Peak Systolic Velocity Ratio (PSVR)
Time Frame: From start of procedure until discharge from treating or referral hospital
From start of procedure until discharge from treating or referral hospital
Peak Systolic Velocity Ratio (PSVR)
Time Frame: 1 month
1 month
Peak Systolic Velocity Ratio (PSVR)
Time Frame: 6 months
6 months
Peak Systolic Velocity Ratio (PSVR)
Time Frame: 1 year
1 year
Peak Systolic Velocity Ratio (PSVR)
Time Frame: 2 years
2 years
Peak Systolic Velocity Ratio (PSVR)
Time Frame: 3 years
3 years
Primary patency rate
Time Frame: From start of procedure until discharge from treating or referral hospital
From start of procedure until discharge from treating or referral hospital
Primary patency rate
Time Frame: 1 month
1 month
Primary patency rate
Time Frame: 6 months
6 months
Primary patency rate
Time Frame: 1 year
1 year
Primary patency rate
Time Frame: 2 years
2 years
Primary patency rate
Time Frame: 3 years
3 years
Secondary patency rate
Time Frame: From start of procedure until discharge from treating or referral hospital
From start of procedure until discharge from treating or referral hospital
Secondary patency rate
Time Frame: 1 month
1 month
Secondary patency rate
Time Frame: 6 months
6 months
Secondary patency rate
Time Frame: 1 year
1 year
Secondary patency rate
Time Frame: 2 years
2 years
Secondary patency rate
Time Frame: 3 years
3 years
Rutherford Becker clinical category and change from baseline for the treated limb
Time Frame: From start of procedure until discharge from treating or referral hospital
From start of procedure until discharge from treating or referral hospital
Rutherford Becker clinical category and change from baseline for the treated limb
Time Frame: 1 month
1 month
Rutherford Becker clinical category and change from baseline for the treated limb
Time Frame: 6 months
6 months
Rutherford Becker clinical category and change from baseline for the treated limb
Time Frame: 1 year
1 year
Rutherford Becker clinical category and change from baseline for the treated limb
Time Frame: 2 years
2 years
Rutherford Becker clinical category and change from baseline for the treated limb
Time Frame: 3 years
3 years
Ankle brachial index (ABI) and change from baseline for the treated limb
Time Frame: From start of procedure until discharge from treating or referral hospital
From start of procedure until discharge from treating or referral hospital
Ankle brachial index (ABI) and change from baseline for the treated limb
Time Frame: 1 month
1 month
Ankle brachial index (ABI) and change from baseline for the treated limb
Time Frame: 6 months
6 months
Ankle brachial index (ABI) and change from baseline for the treated limb
Time Frame: 1 year
1 year
Ankle brachial index (ABI) and change from baseline for the treated limb
Time Frame: 2 years
2 years
Ankle brachial index (ABI) and change from baseline for the treated limb
Time Frame: 3 years
3 years
Wound healing as measured by aggregate ulcer size and its change from baseline
Time Frame: From start of procedure until discharge from treating or referral hospital
From start of procedure until discharge from treating or referral hospital
Wound healing as measured by aggregate ulcer size and its change from baseline
Time Frame: 1 month
1 month
Wound healing as measured by aggregate ulcer size and its change from baseline
Time Frame: 6 months
6 months
Wound healing as measured by aggregate ulcer size and its change from baseline
Time Frame: 1 year
1 year
Wound healing as measured by aggregate ulcer size and its change from baseline
Time Frame: 2 years
2 years
Wound healing as measured by aggregate ulcer size and its change from baseline
Time Frame: 3 years
3 years
Walking capacity and change from baseline
Time Frame: From start of procedure until discharge from treating or referral hospital
From start of procedure until discharge from treating or referral hospital
Walking capacity and change from baseline
Time Frame: 1 month
1 month
Walking capacity and change from baseline
Time Frame: 6 months
6 months
Walking capacity and change from baseline
Time Frame: 1 year
1 year
Walking capacity and change from baseline
Time Frame: 2 years
2 years
Walking capacity and change from baseline
Time Frame: 3 years
3 years
Quality of Life Measures and change from baseline
Time Frame: From start of procedure until discharge from treating or referral hospital
From start of procedure until discharge from treating or referral hospital
Quality of Life Measures and change from baseline
Time Frame: 1 month
1 month
Quality of Life Measures and change from baseline
Time Frame: 6 months
6 months
Quality of Life Measures and change from baseline
Time Frame: 1 year
1 year
Quality of Life Measures and change from baseline
Time Frame: 2 years
2 years
Quality of Life Measures and change from baseline
Time Frame: 3 years
3 years
Target lesion mean and maximum treated site percent diameter stenosis (%DS)
Time Frame: 1 year
1 year
Target lesion mean treated site late loss
Time Frame: 1 year
1 year
Target lesion treated site binary restenosis
Time Frame: 1 year
1 year
Treated site Peak Systolic Velocity (PSV)
Time Frame: From start of procedure until discharge from treating or referral hospital
From start of procedure until discharge from treating or referral hospital
Treated site Peak Systolic Velocity (PSV)
Time Frame: 1 month
1 month
Treated site Peak Systolic Velocity (PSV)
Time Frame: 6 months
6 months
Treated site Peak Systolic Velocity (PSV)
Time Frame: 1 year
1 year
Treated site Peak Systolic Velocity (PSV)
Time Frame: 2 years
2 years
Treated site Peak Systolic Velocity (PSV)
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dierk Scheinert, MD, Herz-Zentrum Leipzig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

April 15, 2011

First Submitted That Met QC Criteria

April 22, 2011

First Posted (Estimate)

April 25, 2011

Study Record Updates

Last Update Posted (Actual)

April 11, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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