201
Participants
Start Date
August 31, 2018
Primary Completion Date
April 21, 2022
Study Completion Date
December 20, 2023
Drug Eluting Stent - Below the Knee
Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm
Standard PTA Control Arm
The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
HAGA Ziekenhuis (Haga Ziekenhuis van Den Haag), The Hague
ZOL Genk (Ziekenhuis Oost-Limburg), Genk
UZ Gent (Universitair Ziekenhuis Gent), Ghent
AZ Sint-Blasius, Dendermonde
New York University Medical Center, New York
Mount Sinai Medical Center, New York
Saint Vincent Consultants in Cardiovascular Diseases at St. Vincent Hospital, Erie
Amputation Prevention Center of North Carolina, Cary
NC Heart and Vascular Research, LLC, Raleigh
Wake Medical Center, Raleigh
Clinique Pasteur, Toulouse
Bradenton Cardiology, Bradenton
Jackson-Madison County General Hospital, Jackson
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital, Columbus
CHU Nantes, Nantes
Cleveland Clinic, Cleveland
Advanced Cardiac & Vascular Centers for Amputation Prevention, Grand Rapids
United Heart and Vascular Clinic, Saint Paul
Washington University School of Medicine, St Louis
Cardiovascular Institute of the South Clinical Research Corporation, Houma
Willis Knighton Bossier Medical Center - Grace Research, LLC, Bossier City
Arkansas Heart Hospital, Little Rock
St. Bernards Medical Center, Jonesboro
Integris Baptist Medical Center, Oklahoma City
Hopital Paris Saint Joseph, Paris
Hopital Europeen Georges Pompidou, Paris
THR Presbyterian Plano, Plano
Heart Hospital of Austin, Austin
Texas Tech University Health, Lubbock
Colorado VA, Denver
New Mexico Heart Institute, PA, Albuquerque
University of California, San Francisco, San Francisco
Hackensack University Medical Center, Hackensack
Holy Name Medical Center, Teaneck
Tokyo Bay Urayasu Ichikawa Medical Center, Urayasu-shi
Kokura Memorial Hospital, Kitakyushu
Asahikawa Medical University Hospital, Asahikawa-shi
Kansai Rosai Hospital, Amagasaki
Nara Medical University Hospital, Kashihara
Kishiwada Tokushukai Hospital, Kishiwada
Tokyo Medical and Dental University, Medical Hospital, Bunkyō-Ku
Toho University Ohashi Medical Center, Meguro City
Lead Sponsor
Boston Scientific Corporation
INDUSTRY