New device aims to save limbs in patients with severe leg artery disease

NCT ID NCT04227899

First seen Nov 03, 2025 · Last updated May 25, 2026 · Updated 22 times

Summary

This study tests a new device called the Esprit BTK System, which is a small mesh tube that releases medicine to keep leg arteries open. It is for people with critical limb ischemia, a severe condition where blocked arteries cause pain and risk of amputation. About 261 participants will receive either the new device or standard treatment to see if it helps save limbs and keep arteries open longer.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • Anmed Health

    Anderson, South Carolina, 29621, United States

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211, United States

  • Ascension St. John Jane Phillips

    Bartlesville, Oklahoma, 74006, United States

  • Auckland City Hospital

    Auckland, Auckland, 1023, New Zealand

  • Baylor All Saints Medical Center at Fort Worth

    Fort Worth, Texas, 76104, United States

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360, United States

  • Changi General Hospital

    Singapore, 529889, Singapore

  • Charlton Memorial Hospital

    Russells Mills, Massachusetts, 02720, United States

  • Comprehensive Integrated Care

    Gilbert, Arizona, 85233, United States

  • Deborah Heart & Lung Center

    Browns Mills, New Jersey, 08015, United States

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32218, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666, United States

  • Jackson Heart Clinic

    Jackson, Mississippi, 39216, United States

  • James J. Peters VA Medical Center

    The Bronx, New York, 10468, United States

  • Lankenau Institute for Medical Research

    Bryn Mawr, Pennsylvania, 19096, United States

  • Manatee Memorial Hospital

    Bradenton, Florida, 34208, United States

  • Mission Cardiovascular Research Institute

    Fremont, California, 94538, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • NC Heart & Vascular Research

    Raleigh, North Carolina, 27607, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • National Taiwan University Hospital

    Taipei, Zhongzheng, 100, Taiwan

  • New York Presbyterian Hospital/Cornell University

    New York, New York, 10065, United States

  • New York-Presbyterian/Columbia University Medical Center

    New York, New York, 10032, United States

  • Palm Vascular Centers

    Miami Beach, Florida, 33140, United States

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • Pinnacle Health System

    Wormleysburg, Pennsylvania, 17043, United States

  • Prince of Wales Hospital

    Hong Kong, Hong Kong

  • Prince of Wales Private Hospital

    Randwick, New South Wales, 2031, Australia

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Saint Vincent Consultants in Cardiovascular Diseases

    Erie, Pennsylvania, 16502, United States

  • San Antonio Vascular and Endovascular Clinic

    San Antonio, Texas, 78221, United States

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009, Australia

  • St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135, United States

  • St. Helena Hospital

    Deer Park, California, 94574, United States

  • St. Joseph Hospital

    Orange, California, 92868, United States

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308, United States

  • Texas Tech University Health Sciences Center at Lubbock

    Lubbock, Texas, 79430, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The Iowa Clinic

    West Des Moines, Iowa, 50266, United States

  • The Lindner Center

    Cincinnati, Ohio, 45255, United States

  • UCSF Fresno

    Fresno, California, 93701, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Colorado Hospital

    Aurora, Colorado, 80045, United States

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390, United States

  • Vascular Institute of Atlantic Medical Imaging

    Pomona, New Jersey, 08240, United States

  • Via Christi Regional Medical Center - St. Francis Campus

    Wichita, Kansas, 67226, United States

  • Wellmont CVA Heart Institute

    Kingsport, Tennessee, 37660, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510, United States

Conditions

Explore the condition pages connected to this study.