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

PHASE3CompletedINTERVENTIONAL
Enrollment

201

Participants

Timeline

Start Date

August 31, 2018

Primary Completion Date

April 21, 2022

Study Completion Date

December 20, 2023

Conditions
Critical Limb Ischemia
Interventions
COMBINATION_PRODUCT

Drug Eluting Stent - Below the Knee

Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm

DEVICE

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.

Trial Locations (42)

2566

HAGA Ziekenhuis (Haga Ziekenhuis van Den Haag), The Hague

3600

ZOL Genk (Ziekenhuis Oost-Limburg), Genk

9000

UZ Gent (Universitair Ziekenhuis Gent), Ghent

9200

AZ Sint-Blasius, Dendermonde

10016

New York University Medical Center, New York

10029

Mount Sinai Medical Center, New York

16544

Saint Vincent Consultants in Cardiovascular Diseases at St. Vincent Hospital, Erie

27518

Amputation Prevention Center of North Carolina, Cary

27607

NC Heart and Vascular Research, LLC, Raleigh

27610

Wake Medical Center, Raleigh

31076

Clinique Pasteur, Toulouse

34205

Bradenton Cardiology, Bradenton

38305

Jackson-Madison County General Hospital, Jackson

43214

OhioHealth Research and Innovation Institute - Riverside Methodist Hospital, Columbus

44000

CHU Nantes, Nantes

44195

Cleveland Clinic, Cleveland

49525

Advanced Cardiac & Vascular Centers for Amputation Prevention, Grand Rapids

55102

United Heart and Vascular Clinic, Saint Paul

63110

Washington University School of Medicine, St Louis

70360

Cardiovascular Institute of the South Clinical Research Corporation, Houma

71111

Willis Knighton Bossier Medical Center - Grace Research, LLC, Bossier City

72211

Arkansas Heart Hospital, Little Rock

72401

St. Bernards Medical Center, Jonesboro

73112

Integris Baptist Medical Center, Oklahoma City

75014

Hopital Paris Saint Joseph, Paris

75015

Hopital Europeen Georges Pompidou, Paris

75093

THR Presbyterian Plano, Plano

78756

Heart Hospital of Austin, Austin

79430

Texas Tech University Health, Lubbock

80220

Colorado VA, Denver

87102

New Mexico Heart Institute, PA, Albuquerque

94143

University of California, San Francisco, San Francisco

07601

Hackensack University Medical Center, Hackensack

07666

Holy Name Medical Center, Teaneck

279-0001

Tokyo Bay Urayasu Ichikawa Medical Center, Urayasu-shi

802-8555

Kokura Memorial Hospital, Kitakyushu

078-8510

Asahikawa Medical University Hospital, Asahikawa-shi

660-8511

Kansai Rosai Hospital, Amagasaki

634-8522

Nara Medical University Hospital, Kashihara

596-8522

Kishiwada Tokushukai Hospital, Kishiwada

113-8510

Tokyo Medical and Dental University, Medical Hospital, Bunkyō-Ku

153-8515

Toho University Ohashi Medical Center, Meguro City

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY