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NCT06872905Recruiting

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

W.L.Gore & Associates

Start Date

5/30/2025

Completion Date

8/16/2027

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).

Detailed 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.

Eligibility Criteria

Age Range: 18 years to 100 years

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. \-

Interventions

DEVICE

GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)

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Conditions

Aortoiliac Occlusive Disease

Locations

University of California

Fresno, California 93721

United States

University of South Florida

Tampa, Florida 33606

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905

United States

Cooper University Hospital

Camden, New Jersey 08103

United States

Rutgers

New Brunswick, New Jersey 08901

United States

Research Foundation SUNY Buffalo

Buffalo, New York 14203

United States

Mount Sinai Medical Center

New York, New York 10029

United States

Research Foundation at SUNY Syracuse

Syracuse, New York 13210

United States

Atrium Health Sanger Heart & Vascular Institute

Charlotte, North Carolina 28203

United States

Ohio State University Medical Center

Columbus, Ohio 43210

United States

Geisinger Medical Center

Danville, Pennsylvania 17822

United States

University Of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Sanford Clinical Vascular Associates

Sioux Falls, South Dakota 57105

United States

Wellmont Holston Valley Medical Center

Kingsport, Tennessee 37760

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

The University of Texas Austin

Austin, Texas 78712

United States

Carilion Clinic

Roanoke, Virginia 24016

United States

Marshfield Hospital

Marshfield, Wisconsin 54449

United States

Marshfield Medical Center - Marshfield

Marshfield, Wisconsin 54449

United States

Azienda Ospedaliero-Universitaria di Padova

Padova, 35131

Italy

Ospedale di Circolo e Fondazione Macchi

Varese, 21100

Italy

Amsterdam UMC Research BV

Amsterdam, 1105

Netherlands

Franciscus

Rotterdam, 3045 PM

Netherlands

Hospital General Universitario de Alicante

Alicante, 03010

Spain

Greater Glasgow Health Board

Glasgow, G12 OXH

United Kingdom