The ABSORB BTK (Below The Knee) Clinical Investigation

NCT01341340 | Terminated DMC

• 1 other identifier: 10-112
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atherosclerosis; Peripheral Artery Disease; Peripheral Vascular Disease; PAD; Claudication; Critical Limb Ischemia; Lower Limb Disease; Peripheral Arterial Occlusive Disease; PAOD; PVD

Keywords

Stent; Infrapopliteal; Tibial; Limb Salvage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (108)

• Device Success

  From start of index procedure to end of index procedure

• Technical Success

  From start of index procedure to end of index procedure

• Clinical Success

  Within 48 hours after the index procedure or at hospital discharge, whichever is sooner

• Death

  From start of procedure until discharge from treating or referral hospital

• Death

  1 month

Study Arms (1)

Everolimus Eluting BVS

EXPERIMENTAL

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

Device: Everolimus Eluting BVS

Interventions

Everolimus Eluting BVS DEVICE

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

Everolimus Eluting BVS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 18 and ≤ 80 years of age.
• History of symptomatic critical limb ischemia (CLI) (Rutherford Becker Clinical Category 4 or 5).
• Subject is able to take at least one type of thienopyridine (e.g. clopidogrel) and acetylsalicylic acid (eg. Aspirin/ASA).
• The subject must have a life-expectancy of more than 1 year.
• 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.
• 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.
• Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site.
• 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.
• 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.
• Target lesion length is visually estimated to be ≤ 24 mm.
• 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.
• 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.
• Inflow between the proximal iliac and distal popliteal is unobstructed (free from ≥ 50% stenosis) as confirmed by angiography. \[Note: Assessment may be made after interventions proximal to the target lesion.\]
• 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.
• 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.

You may not qualify if:

• Subject is unable to understand or unwilling to cooperate with study procedures.
• The subject is mentally ill or belongs to a vulnerable population.
• Subject is currently breast-feeding, pregnant, or intends to become pregnant prior to completion of the 1 year angiographic follow-up.
• Subject has had any type of amputation to the ipsilateral or contralateral extremity.
• Subject is unable to walk. (with assistance is accepted)
• Subject has had recent major surgery (requiring general or regional anesthesia or impacting major organ systems) within the last 3 months.
• Subject has received, or is on the waiting list for a major organ transplant.
• Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 2, 3 or 6.
• Subject has any type of infection, until treated successfully.
• Subject has osteomyelitis present in the distal ipsilateral extremity.
• Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• The subject has a history of prior life-threatening contrast media reaction.
• Subject is receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the procedure.
• 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.).
• Subject is receiving or will receive inhibitors of CYP3A or inducers of CYP3A within 30 days prior to or following the procedure.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Vascular International Bvba

Diegem, Belgium

Location

MeSH Terms

Conditions

Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication; Chronic Limb-Threatening Ischemia; Peripheral Arterial Occlusive Disease 1

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Pathologic Processes; Ischemia

Study Officials

• Dierk Scheinert, MD

  Herz-Zentrum Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 25, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 11, 2019

Record last verified: 2019-04

Locations

BE (1)