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The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT03551496•Boston Scientific Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is 18 years or older and has signed and dated the trial informed consent form (ICF)
•2. Subject is willing and able to comply with the trial testing, procedures and follow-up schedule
•3. 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
•4. 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
•1. Stenotic, restenotic or occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies).
•2. Target lesion(s) must be at least 4cm above the ankle joint
•3. A single target lesion per vessel, in up to 2 vessels, in a single limb
•4. Degree of stenosis ≥ 70% by visual angiographic assessment
•5. Reference vessel diameter is between 2.5 - 3.25mm for phase A RCT
•6. 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)
+5 more criteria

Exclusion Criteria

•1. Life expectancy ≤ 1year
•2. Stroke ≤ 90 days prior to the procedure date
•3. Prior or planned major amputation in the target limb
•4. Previous surgery in the target vessel(s) (including prior ipsilateral crural bypass)
•5. Previously implanted stent in the target vessel(s)
•6. Failed PTA of target lesion/vessel ≤ 60 days prior to the procedure date
•7. Renal failure as measured by a GFR ≤ 30ml/min per 1.73m2, measured ≤ 30 days prior to the procedure date
•8. Subject has a platelet count ≤ 50 or ≥ 600 X 103/µL ≤ 30 days prior to the procedure date
•9. NYHA class IV heart failure
•10. Subject has symptomatic coronary artery disease (ie, unstable angina)
+17 more criteria

Locations (42)

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

Key Dates

Start Date

August 31, 2018

Primary Completion Date

April 21, 2022

Completion Date

December 20, 2023

Last Updated

July 1, 2024

Enrollment

201

ACTUAL participants

Conditions

Critical Limb Ischemia

Interventions

Drug Eluting Stent - Below the Knee

COMBINATION_PRODUCT

Standard PTA Control Arm

DEVICE

Nutrition in Patient With Critical Limb Ischemia

NCT03529019

Critical Limb IschemiaMalnutrition+1 more

View study

RECRUITINGPHASE4

Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease

NCT05854615

Critical Limb IschemiaBuerger's Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Nutrition in Patient With Critical Limb Ischemia

Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease

Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention

miRNAs in Critical Limb Ischemia (miRNACLI)

MOTIV BTK Randomized Controlled Trial

FAZA PET/MRI in CLI Patients Pre and Post Revascularization