New dissolving scaffold could save legs from amputation

NCT ID NCT05406622

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new device called the MOTIV Sirolimus-Eluting Bioresorbable Vascular Scaffold for people with severe leg artery disease (critical limb ischemia). The scaffold slowly releases medicine to keep the artery open and then dissolves over time. Researchers compare it to standard balloon angioplasty in 292 adults to see if it better prevents amputation, re-blockage, or the need for repeat procedures.

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Conditions

The condition(s) this trial relates to.

Chronic Limb-Threatening Ischemia limb ischemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Adventist Health

    St. Helena, California, 94574, United States

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453, United States

  • Ballad Health System

    Kingsport, Tennessee, 37660, United States

  • Baylor Research Institute

    Plano, Texas, 75093, United States

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301, United States

  • California Heart and Vascular Clinic

    El Centro, California, 92243, United States

  • Cardiovascular Institute of the South

    Houma, Louisiana, 98374, United States

  • Cardiovascular Medicine PC

    Davenport, Iowa, 52803, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • ClinRe

    Thornton, Colorado, 80023, United States

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32256, United States

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666, United States

  • Miami Cardiac & Vascular Institute

    Miami, Florida, 33176, United States

  • Mission Cardiovascular Research Institute

    Fremont, California, 94538, United States

  • North Dallas Research Associates

    McKinney, Texas, 75069, United States

  • Pacific Vascular Institute

    ‘Aiea, Hawaii, 96701, United States

  • Palm Vascular

    Miami Beach, Florida, 33140, United States

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30369, United States

  • Presbyterian Healthcare Services

    Albuquerque, New Mexico, 87106, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Stanford University Medical Center

    Stanford, California, 94304, United States

  • Texas Tech University

    Lubbock, Texas, 79430, United States

  • The Vascular Care Group - Wellesley

    Wellesley, Massachusetts, 02482, United States

  • UnityPoint Health Trinity Bettendorf Hospital

    Bettendorf, Iowa, 52722, United States

  • University Leipzig

    Leipzig, Leipzig, 04109, Germany

  • Vascular Care Connecticut

    Darien, Connecticut, 06820, United States