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New stent study aims to keep blood flowing in blocked aortic arteries

NCT ID NCT06872905

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Updated 2 times

Summary

This study looks at how safe and effective a special stent (VBX) is for treating blocked arteries near the aorta in the lower belly. About 158 people who already had this stent placed at least a year ago will be followed. The goal is to see if the artery stays open and if there are any serious heart problems or need for another procedure within 30 days.

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.

Participants

About 158 people

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

Started

May 2025

Expected to finish

Aug 2027

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.

Who is studied

As described in the background section, patients with aortoiliac occlusive disease are treated with various surgical and endovascular therapies to improve arterial blood flow to the lower extremity. This study will retrospectively evaluate a population of patients that have had covered endovascular reconstruction of the aortic bifurcation (CERAB) with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. The study has been designed with standard eligibility criteria to evaluate the safety and effectiveness of the VBX Device when used in a CERAB for an aortoiliac occlusive disease patient population. Considering the nature of aortoiliac occlusive disease, elderly patients (≥ 65 years old) can represent a significant number of patients enrolled in this study. This population can include patients with cognitive disorder or severe dementia. According to EU regulation, elderly patients are considered vulnerable population. However, considering the retrospective nature of the study design, t

Ages

18 to 100 years

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: 1. Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD). 2. Patient was implanted with the VBX Device in the aortic position during a CERAB procedure. 3. Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date. 4. Age ≥18 years at the time of CERAB procedure. 5. Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC) - Exclusion Criteria: 1. Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure. 2. Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery). 3. Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints. \-

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Conditions

The condition(s) this trial relates to.

arteriosclerosis obliterans Leriche syndrome

As listed by the trial registrant

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

Aortoiliac occlusive disease

How to take part

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

  1. The places running it

    26 sites in 5 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

  • Amsterdam UMC Research BV

    RECRUITING

    Amsterdam, 1105, Netherlands

  • Atrium Health Sanger Heart & Vascular Institute

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Azienda Ospedaliero-Universitaria di Padova

    NOT_YET_RECRUITING

    Padova, 35131, Italy

  • Carilion Clinic

    RECRUITING

    Roanoke, Virginia, 24016, United States

  • Cooper University Hospital

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Franciscus

    RECRUITING

    Rotterdam, 3045 PM, Netherlands

  • Geisinger Medical Center

    RECRUITING

    Danville, Pennsylvania, 17822, United States

  • Greater Glasgow Health Board

    RECRUITING

    Glasgow, G12 OXH, United Kingdom

  • Hospital General Universitario de Alicante

    RECRUITING

    Alicante, 03010, Spain

  • Marshfield Hospital

    RECRUITING

    Marshfield, Wisconsin, 54449, United States

  • Marshfield Medical Center - Marshfield

    RECRUITING

    Marshfield, Wisconsin, 54449, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mount Sinai Medical Center

    RECRUITING

    New York, New York, 10029, United States

  • Ohio State University Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Ospedale di Circolo e Fondazione Macchi

    RECRUITING

    Varese, 21100, Italy

  • Research Foundation SUNY Buffalo

    RECRUITING

    Buffalo, New York, 14203, United States

  • Research Foundation at SUNY Syracuse

    RECRUITING

    Syracuse, New York, 13210, United States

  • Rutgers

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Sanford Clinical Vascular Associates

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • The University of Texas Austin

    RECRUITING

    Austin, Texas, 78712, United States

  • University Of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of California

    RECRUITING

    Fresno, California, 93721, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Wellmont Holston Valley Medical Center

    RECRUITING

    Kingsport, Tennessee, 37760, United States

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