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New stent aims to open blocked veins and heal leg ulcers

NCT ID NCT05409976

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

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

Summary

This trial is testing a new stent (a small mesh tube) to treat blockages in the large vein in the abdomen (inferior vena cava) and nearby leg veins. The study involves 136 adults with symptoms like leg ulcers, pain, or swelling. Doctors will place the stent to keep the vein open and check if it stays clear and safe over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
GORE VIAFORT vascular stent (a mesh tube placed inside a vein to keep it open)
What this could lead to
If it works, this stent could offer a safe and effective way to treat blocked veins in the abdomen and legs, relieving pain, swelling, and leg ulcers.
What could go wrong
This is an early-stage, single-arm study with no comparison group, so results may not apply to everyone. Risks include stent blockage, bleeding, or injury to the vein.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

chronic venous insufficiency 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

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Alexianer Klinikum Hochsauerland GmbH

    Arnsberg, 59759, Germany

  • Atrium Health-Sanger Heart and Vascular Institute

    Charlotte, North Carolina, 28204, United States

  • Auckland City Hospital

    Auckland, New Zealand

  • Flinders Medical Centre

    Adelaide, South Australia, 5042, Australia

  • Hesperia Hospital

    Modena, 41125, Italy

  • MedStar Washington Hospital Center

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

  • Mount Sinai Medical Center

    New York, New York, 10029, United States

  • Northwestern

    Chicago, Illinois, 60611, United States

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Sentara

    Norfolk, Virginia, 23507, United States

  • St Thomas' Hospital

    London, SE1 7EH, United Kingdom

  • Stanford University School of Medicine

    Stanford, California, 94305, United States

  • University College Hospital GALWAY /Clinical Research Facility Galway

    Galway, Connacht, H91 YR71, Ireland

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Universitätsklinikum Aachen

    Aachen, 52074, Germany

  • Weill Cornell Medical College

    New York, New York, 10065, United States

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