Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease

Last updated: May 27, 2026
Sponsor: W.L.Gore & Associates
Overall Status: Active - Recruiting

Phase

N/A

Condition

Peripheral Arterial Occlusive Disease

Treatment

GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)

Clinical Study ID

NCT06872905
VBX 24-03
  • Ages 18-100
  • All Genders

Study Summary

The study will assess the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis ("VBX Device" or also referred to as "VBX Stent Graft") in a post approval setting and evaluate the quality of the use in covered endovascular reconstruction of the aortic bifurcation (CERAB) to treat Aortoiliac Occlusive Disease (AIOD).

Eligibility Criteria

Inclusion

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 CERABprocedure.

  3. Patient was treated with the CERAB procedure a minimum of 1 year before enrollmentdate.

  4. Age ≥18 years at the time of CERAB procedure.

  5. Obtain patient informed consent or waiver according to local Institutional ReviewBoard (IRB)/Ethics Committee (EC) -

Exclusion

Exclusion Criteria:

  1. Patient with prior stenting in the aortic or common iliac artery at the time ofCERAB 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 theCERAB procedure date that can confound the study endpoints.

Study Design

Total Participants: 158
Treatment Group(s): 1
Primary Treatment: GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
Phase:
Study Start date:
May 30, 2025
Estimated Completion Date:
August 16, 2027

Study Description

A minimum of 158 adult subjects will be enrolled at up to a minimum of 20 sites in the U.S. and Europe. Data will be collected retrospectively and found within existing site files at Baseline, Treatment, Discharge, Pre-12-Month Follow-up, 12-Month Follow-Up, Subsequent Follow-Up Visits.

Connect with a study center

  • Azienda Ospedaliero-Universitaria di Padova

    Padova, 35131
    Italy

    Site Not Available

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100
    Italy

    Active - Recruiting

  • Amsterdam UMC Research BV

    Amsterdam, 1105
    Netherlands

    Active - Recruiting

  • Franciscus

    Rotterdam, 3045 PM
    Netherlands

    Active - Recruiting

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Active - Recruiting

  • Greater Glasgow Health Board

    Glasgow, G12 OXH
    United Kingdom

    Active - Recruiting

  • University of California

    Fresno, California 93721
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Cooper University Hospital

    Camden, New Jersey 08103
    United States

    Active - Recruiting

  • Rutgers

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Research Foundation SUNY Buffalo

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • Mount Sinai Medical Center

    New York, New York 10029
    United States

    Active - Recruiting

  • Research Foundation at SUNY Syracuse

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • Atrium Health Sanger Heart & Vascular Institute

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • Ohio State University Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Active - Recruiting

  • University Of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Sanford Clinical Vascular Associates

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • Wellmont Holston Valley Medical Center

    Kingsport, Tennessee 37760
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • The University of Texas Austin

    Austin, Texas 78712
    United States

    Active - Recruiting

  • Carilion Clinic

    Roanoke, Virginia 24016
    United States

    Active - Recruiting

  • Marshfield Hospital

    Marshfield, Wisconsin 54449
    United States

    Active - Recruiting

  • Marshfield Medical Center - Marshfield

    Marshfield, Wisconsin 54449
    United States

    Active - Recruiting

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