A Randomized Trial Comparing the Drug-Eluting Stent (DES) Below-the-Knee (BTK) Vascular Stent System (DES BTK Vascular Stent System) vs Percutaneous Transluminal Angioplasty (PTA) Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Critical Limb Ischemia
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 201
- Locations
- 42
- Primary Endpoint
- Number of Participants With Primary Patency
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Single phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).
Detailed Description
A global, prospective, multicenter, 2:1 randomized trial evaluating the safety and effectiveness of the DES BTK Vascular Stent System compared to standard percutaneous transluminal angioplasty to treat infrapopliteal artery lesions in subjects with critical limb ischemia(CLI). Approximately 201 subjects will be randomized/enrolled to support a 2:1 randomization.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is 18 years or older and has signed and dated the trial informed consent form (ICF)
- •Subject is willing and able to comply with the trial testing, procedures and follow-up schedule
- •Subject has chronic, symptomatic lower limb ischemia, determined by Rutherford categories 4 or 5 in the target limb, with wound(s) confined to toes/forefoot
- •Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator
- •Intra-procedure Inclusion Criteria:
- •Stenotic, restenotic or occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies).
- •Target lesion(s) must be at least 4cm above the ankle joint
- •A single target lesion per vessel, in up to 2 vessels, in a single limb
- •Degree of stenosis ≥ 70% by visual angiographic assessment
- •Reference vessel diameter is between 2.5 - 3.25mm for phase A RCT
Exclusion Criteria
- •Life expectancy ≤ 1year
- •Stroke ≤ 90 days prior to the procedure date
- •Prior or planned major amputation in the target limb
- •Previous surgery in the target vessel(s) (including prior ipsilateral crural bypass)
- •Previously implanted stent in the target vessel(s)
- •Failed PTA of target lesion/vessel ≤ 60 days prior to the procedure date
- •Renal failure as measured by a GFR ≤ 30ml/min per 1.73m2, measured ≤ 30 days prior to the procedure date
- •Subject has a platelet count ≤ 50 or ≥ 600 X 103/µL ≤ 30 days prior to the procedure date
- •NYHA class IV heart failure
- •Subject has symptomatic coronary artery disease (ie, unstable angina)
Outcomes
Primary Outcomes
Number of Participants With Primary Patency
Time Frame: 12 months
Twelve-Month Primary Patency defined as a binary endpoint to be determined via duplex ultrasound (DUS) measuring flow at the 12-month follow-up visit, in the absence of clinically-driven target lesion revascularization (TLR) or bypass of the target lesion. Data table consists of the number of participants with flow as assessed by DUS.
Number of Participants Free From Major Adverse Events (MAE)
Time Frame: 12 months
The primary safety endpoint assesses freedom from major adverse events (MAE) at 12 months post-procedure. (MAE is defined as: above ankle amputation in index limb; major re-intervention; and perioperative (30 day) mortality)