The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia

Completed · Phase 3

Conditions studied: Critical Limb Ischemia

In brief

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).

Key facts

Study ID: NCT03551496
Run by: Boston Scientific Corporation
People needed: 201
Starts: 2018-08-31
Expected to finish: 2023-12-20
Last updated by the study team: 2024-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Total target lesion length (or series of lesion segments) to be treated is ≤ 70 mm for phase A RCT prior to the data monitoring committee's approval for stent overlap. (Note: Lesion segment(s) must be fully covered with one DES BTK stent, if randomized to stent)
Total target lesion length (or series of lesion segments) to be treated is ≤ 140 mm for phase A RCT after the data monitoring committee's approval for stent overlap (Note: Lesion segment(s) must be fully covered with up to two DES BTK stents, if randomized to stent)
Target vessel(s) reconstitute(s) at or above the stenting limit zone (4cm above the ankle joint)
Target lesion(s) is located in an area that may be stented without blocking access to patent main branches
Treatment of all above the knee inflow lesion(s) is successful prior to treatment of the target lesion
Guidewire has successfully crossed the target lesion(s)

You may not qualify if…

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)
History of myocardial infarction or thrombolysis ≤ 90 days prior to the procedure date
Non-atherosclerotic disease resulting in occlusion (eg, embolism, Buerger's disease, vasculitis)
Subject is currently taking Canagliflozin
Body Mass Index (BMI) <18
Active septicemia or bacteremia
Coagulation disorder, including hypercoagulability
Contraindication to anticoagulation or antiplatelet therapy
Known allergies to stent or stent components
Known allergy to contrast media that cannot be adequately pre-medicated prior to the interventional procedure
Known hypersensitivity to heparin
Subject is on a high dose of steroids or is on immunosuppressive therapy
Subject is currently participating, or plans to participate in, another investigational trial that may confound the results of this trial (unless written approval is received from the Boston Scientific study team)
Intra-procedure Exclusion Criteria
Angiographic evidence of intra-arterial acute/subacute thrombus or presence of atheroembolism
Treatment required in > 2 target vessels (Note: a target lesion originating in one vessel and extending into another vessel is considered 1 target vessel)

Where it is running

St. Bernards Medical Center — Jonesboro, Arkansas, United States
Arkansas Heart Hospital — Little Rock, Arkansas, United States
University of California, San Francisco — San Francisco, California, United States
Colorado VA — Denver, Colorado, United States
Bradenton Cardiology — Bradenton, Florida, United States
Willis Knighton Bossier Medical Center - Grace Research, LLC — Bossier City, Louisiana, United States
Cardiovascular Institute of the South Clinical Research Corporation — Houma, Louisiana, United States
Advanced Cardiac & Vascular Centers for Amputation Prevention — Grand Rapids, Michigan, United States
United Heart and Vascular Clinic — Saint Paul, Minnesota, United States
Washington University School of Medicine — St Louis, Missouri, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Holy Name Medical Center — Teaneck, New Jersey, United States
New Mexico Heart Institute, PA — Albuquerque, New Mexico, United States
New York University Medical Center — New York, New York, United States
Mount Sinai Medical Center — New York, New York, United States
Amputation Prevention Center of North Carolina — Cary, North Carolina, United States
NC Heart and Vascular Research, LLC — Raleigh, North Carolina, United States
Wake Medical Center — Raleigh, North Carolina, United States
Cleveland Clinic — Cleveland, Ohio, United States
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital — Columbus, Ohio, United States
Integris Baptist Medical Center — Oklahoma City, Oklahoma, United States
Saint Vincent Consultants in Cardiovascular Diseases at St. Vincent Hospital — Erie, Pennsylvania, United States
Jackson-Madison County General Hospital — Jackson, Tennessee, United States
Heart Hospital of Austin — Austin, Texas, United States
Texas Tech University Health — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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