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Clinical trialNCT03551496CompletedPhase 3Interventional

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

SponsorBoston Scientific CorporationEnrollment201Critical Limb Ischemia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Hendrik van Overhagen, MD

    HAGA Ziekenhuis (HagaZiekenhuis van Den Haag)

    Principal Investigator
  • Jihad Mustapha, MD

    Advanced Cardiac & Vascular Centers for Amputation Prevention

    Principal Investigator
  • Masato Nakamura, MD, PhD

    Toho University Ohashi Medical Center - Division of Cardiovascular Medicine

    Principal Investigator
  • Patrick Geraghty, MD

    Washington University School of Medicine

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

42 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Belgium
  • Az Sint-Blasius

    Dendermonde, Belgium

  • Zol Genk (ziekenhuis Oost-Limburg)

    Genk, Belgium

  • Uz Gent (universitair Ziekenhuis Gent)

    Ghent, Belgium

France
  • Chu Nantes

    Nantes, France

  • Hopital Europeen Georges Pompidou

    Paris, France

  • Hopital Paris Saint Joseph

    Paris, France

  • Clinique Pasteur

    Toulouse, France

Japan
  • Tokyo Bay Urayasu Ichikawa Medical Center

    Urayasu-shi, Chiba, Japan

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, Japan

  • Asahikawa Medical University Hospital

    Asahikawa-shi, Hokkaido, Japan

  • Kansai Rosai Hospital

    Amagasaki, Hyōgo, Japan

  • Nara Medical University Hospital

    Kashihara, Nara, Japan

  • Kishiwada Tokushukai Hospital

    Kishiwada, Osaka, Japan

  • Tokyo Medical and Dental University, Medical Hospital

    Bunkyō-Ku, Tokyo, Japan

  • Toho University Ohashi Medical Center

    Meguro City, Tokyo, Japan

Netherlands
  • Haga Ziekenhuis (haga Ziekenhuis Van Den Haag)

    The Hague, Netherlands

United States
  • 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

  • Mount Sinai Medical Center

    New York, New York, United States

  • New York University 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

2 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Aug 2018
Primary completion
21 Apr 2022
Completion
20 Dec 2023
Last update posted
1 Jul 2024
Registered enrollment
201
Registry id
NCT03551496

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.