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New stent aims to keep leg arteries open longer

NCT ID NCT05811364

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study tests whether a fabric-covered stent (GORE VBX) works better than standard bare metal stents for people with severe blockages in the iliac arteries, which supply blood to the legs. About 244 participants with leg pain or tissue loss will be randomly assigned to receive one of the two stents. The main goal is to see which stent keeps the artery open longer without needing another procedure.

What this could mean

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

Active substance
GORE® VIABAHN® VBX balloon expandable endoprosthesis (a fabric-covered metal stent)
What this could lead to
If it works, this could provide a more durable option for keeping iliac arteries open, reducing the need for repeat procedures.
What could go wrong
This is a randomized trial, but results may not apply to all patients. Stents can still re-narrow or cause complications like clotting or infection.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 244 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jan 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years at time of informed consent signature * Informed Consent Form (ICF) is signed by the subject * Subject can comply with protocol requirements, including follow-up * Patient has symptomatic claudication, rest pain, or minor tissue loss (Rutherford Category 2-5) * Patient has de novo or restenotic lesion(s) found in the common and/or external iliac artery(ies) * Patient has: Unilateral or bilateral single or multiple lesions (\>50% stenosis or chronic total occlusion) each between 4 and 11 cm in length * Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm * Patient has a sufficient (\<50% stenotic) common femoral artery and at least one sufficient (\<50% stenotic) femoral artery (deep or superficial). * Patient has at least one sufficient (\<50% stenotic) infrapopliteal run-off vessel. Exclusion Criteria: * Life expectancy \<1 year * Patient is pregnant at time of informed consent. * Patient has a known allergy to stent or stent graft components (including nitinol, stainless steel, or heparin). * Patient has severe chronic renal insufficiency (serum creatinine level \> 2.5mg/dL) and not undergoing hemodialysis. * Patient has evidence of a systemic infection. * Patient has a known intolerance to antithrombotic medications that prevent compliance with study or control device Instructions for Use. * Patient has had vascular catheterization of the lower extremities within 30 days of randomization (excluding diagnostic angiograms for the study procedure). * Patient has previous stenting in the iliac arteries. * Patient has previous surgical bypass in the target limb. * Patient is currently participating in another investigative clinical study unless received written approval by the sponsor. * Patient has a lesion requiring drug-coated balloon angioplasty, atherectomy, lithotripsy, or any ablative device to facilitate stent delivery. * Patient has an abdominal aortic artery lesion or aneurysm. * Patient has a lesion that requires stent placement within 2 cm of the inguinal ligament. * Patient has isolated common iliac artery stenosis that can be treated with a single device (i.e., common iliac artery stenosis that does not require kissing stents or extend into the external iliac artery). * Patient has outflow disease that requires concomitant interventions (i.e. common femoral endarterectomy or femoral / tibial revascularization).

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Conditions

The condition(s) this trial relates to.

arteriosclerosis obliterans Leriche syndrome peripheral arterial disease

As listed by the trial registrant

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

Aortoiliac occlusive disease Peripheral arterial disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    40 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlanta VA Medical Center

    RECRUITING

    Decatur, Georgia, 30033, United States

  • Atrium Health

    RECRUITING

    Charlotte, North Carolina, 28210, United States

  • Auckland City Hospital

    RECRUITING

    Auckland, New Zealand

  • Azienda Complesso Ospedaliero San Filippo Neri

    RECRUITING

    Roma, Italy

  • Beth Israel Deaconess Medical Center, Inc.

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Central Adelaide Local Health Network Incorporated

    RECRUITING

    Adelaide, Australia

  • Central Arkansas Veterans Healthcare System

    WITHDRAWN

    Little Rock, Arkansas, 72205, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Corewell Health System

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Denver Health and Hospital Authority

    RECRUITING

    Denver, Colorado, 80204, United States

  • East Kent Hospitals University NHS Foundation Trust

    RECRUITING

    Canterbury, United Kingdom

  • Guy's and St Thomas', NHS Foundation Trust

    RECRUITING

    London, United Kingdom

  • Klinikum Stuttgart

    RECRUITING

    Stuttgart, Germany

  • Krankenhaus der Barmherzigen Brüder

    RECRUITING

    Regensburg, Germany

  • Louisiana State University Health Sciences Center

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Mt. Sinai Medical Center

    RECRUITING

    New York, New York, 10029, United States

  • New York University School of Medicine

    RECRUITING

    New York, New York, 10016, United States

  • North Suburban Medical Center

    WITHDRAWN

    Denver, Colorado, 80229, United States

  • Ospedale Niguarda Ca'Granda

    RECRUITING

    Milan, MI, Italy

  • Ospedale San Giovanni Molinette

    RECRUITING

    Turin, Italy

  • Ospedale Santa Maria della Misericordia

    RECRUITING

    Perugia, Italy

  • Portland Health Care System VA

    RECRUITING

    Portland, Oregon, 97239, United States

  • Prince of Wales Hospital

    RECRUITING

    Randwick, Australia

  • Providence Heart & Vascular Institute

    RECRUITING

    Wilsonville, Oregon, 97070, United States

  • Radiology and Imaging Specialists of Lakeland

    RECRUITING

    Lakeland, Florida, 33801, United States

  • Research Foundation SUNY Buffalo

    WITHDRAWN

    Amherst, New York, 14228, United States

  • Rijnstate Hospital

    RECRUITING

    Arnhem, Netherlands

  • Royal Perth Hospital

    RECRUITING

    Nedlands, Australia

  • Sentara Medical Group

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • St. Franziskus Hospital

    RECRUITING

    Münster, Germany

  • Stichting Elisabeth-TweeSteden Ziekenhuis

    RECRUITING

    Tilburg, Netherlands

  • The Curators of the University of Missouri

    RECRUITING

    Columbia, Missouri, 65212, United States

  • The University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Trinity Medical Center

    RECRUITING

    Buffalo, New York, 14214, United States

  • Universitats-Herzzentrum Freiburg Bad Krozingen GmbH

    RECRUITING

    Bad Krozingen, Germany

  • University Hospital Southampton NHS Foundation Trust

    RECRUITING

    Southampton, United Kingdom

  • University Hospitals - Cleveland Medical Center

    RECRUITING

    Ashland, Ohio, 44805, United States

  • University of Florida - Gainesville

    RECRUITING

    Gainesville, Florida, 32608, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33620, United States

  • VA Long Beach Healthcare System

    RECRUITING

    Long Beach, California, 90822, United States

  • VA Western New York Healthcare System

    RECRUITING

    Buffalo, New York, 14215, United States

  • Wellmont Holston Valley Medical Center

    RECRUITING

    Kingsport, Tennessee, 37660, United States

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