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: July 30, 2025
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

  • University of California

    Fresno, California 93721
    United States

    Site Not Available

  • Cooper University Hospital

    Camden, New Jersey 08103
    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

  • Marshfield Hospital

    Marshfield, Wisconsin 54449
    United States

    Active - Recruiting

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