Last updated on June 2019

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

Brief description of study

Two 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 Study Description

Phase A: 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). Phase A RCT will begin with one size of the device: 3.5 mm x 80 mm.

Phase B: A global, prospective, multicenter, non-randomized trial collecting additional safety and effectiveness data for the DES BTK Vascular Stent System to treat infrapopliteal artery lesions in subjects with CLI. Additional stent sizes will be added to the trial upon regulatory approval.

Approximately 201 subjects will be randomized/enrolled to support a 2:1 randomization in the phase A RCT. Assuming the effectiveness endpoint is met in phase A RCT, approximately 100 additional subjects are expected to be enrolled in phase B non-randomized which is structured as a single arm where the enrolled subjects are treated with the DES BTK Vascular Stent System.

Clinical Study Identifier: NCT03551496

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The Iowa Clinic

West Des Moines, IA United States
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St. Bernards Medical Center

Jonesboro, AR United States
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Mount Sinai Medical Center

New York, NY United States
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Holy Name Medical Center

Teaneck, NJ United States
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United Health & Vascular

Saint Paul, MN United States
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Bradenton Cardiology

Bradenton, FL United States
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Baylor College of Medicine

Houston, TX United States
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JFK Medical Center

Atlantis, FL United States
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Arkansas Heart Hospital

Little Rock, AR United States
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Wake Medical Center

Raleigh, NC United States
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Integris Baptist Medical Center

Oklahoma City, OK United States
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Centennial Medical Center

Nashville, TN United States
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Colorado VA

Denver, CO United States
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Cleveland Clinic

Cleveland, OH United States
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THR Presbyterian Plano

Plano, TX United States
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USC University Hospital

Los Angeles, CA United States
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New Mexico Heart Institute, PA

Albuquerque, NM United States
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AZ Sint-Blasius

Dendermonde, Belgium
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CHU Nantes

Nantes, France
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Recruitment Status: Open

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