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
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
Interventions
GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
Conditions
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