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New stent aims to restore blood flow in blocked leg veins

NCT ID NCT05489588

Ongoing Disease control Sponsor: W.L.Gore & Associates Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study tests a new medical device called the GORE VIAFORT stent, which is a small mesh tube placed inside a blocked or narrowed vein in the leg or pelvis to keep it open. The goal is to improve blood flow and reduce symptoms like pain, swelling, and leg ulcers. About 165 adults with these vein problems will receive the stent and be followed for one year to check if it is safe and works well.

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Conditions

The condition(s) this trial relates to.

chronic venous insufficiency May-Thurner syndrome ulcer of lower limbs Varicose Ulcer vascular occlusion disorder vein disorder venous insufficiency venous thromboembolism Venous Thrombosis

As listed by the trial registrant

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

VEIN DISEASE VEIN OCCLUSION VEIN THROMBOSIS VENOUS DISEASE VENOUS LEG ULCER VENOUS OCCLUSION VENOUS STASIS VENOUS STENOSIS VENOUS THROMBOSES VENOUS ULCER

Contacts and locations

Locations

  • Atrium Health-Sanger Heart and Vascular Institute

    Charlotte, North Carolina, 28204, United States

  • Bethesda North

    Cincinnati, Ohio, 45242, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Englewood Hospital & Med Center

    Englewood, New Jersey, 07631, United States

  • Manatee Memorial Hospital

    Bradenton, Florida, 34208, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Medical College of Wisconsin - Froedtert Hospital

    Milwaukee, Wisconsin, 53226, United States

  • Mount Sinai Medical Center

    New York, New York, 10029, United States

  • NC Heart and Vascular Research

    Raleigh, North Carolina, 27519, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Overlake Hospital

    Bellevue, Washington, 98004, United States

  • Sentara General Hospital

    Norfolk, Virginia, 23507, United States

  • Stanford University School of Medicine

    Stanford, California, 94305, United States

  • Stony Brook

    Stony Brook, New York, 11790, United States

  • The Miriam Hospital

    Providence, Rhode Island, 02906, United States

  • UT Southwestern

    Dallas, Texas, 75390, United States

  • University Hospitals Cleveland

    Cleveland, Ohio, 44106, United States

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 14213, United States

  • Vascular Care Group

    Darien, Connecticut, 06820, United States

  • Vascular Care Group

    Wellesley, Massachusetts, 02482, United States

  • Yale University

    New Haven, Connecticut, 06519, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.