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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
Sponsor: W.L.Gore & Associates
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).
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
158
Start Date
2025-05-30
Completion Date
2027-08-16
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
Treatment of Target Lesions with the VBX Device in the aortic and common iliac positions during the CERAB procedure.
Locations (19)
University of California
Fresno, California, United States
University of South Florida
Tampa, Florida, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Cooper University Hospital
Camden, New Jersey, United States
Rutgers
New Brunswick, New Jersey, United States
Research Foundation SUNY Buffalo
Buffalo, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Ohio State University Medical Center
Columbus, Ohio, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States
The University of Texas Austin
Austin, Texas, United States
Carilion Clinic
Roanoke, Virginia, United States
Marshfield Hospital
Marshfield, Wisconsin, United States
Azienda Ospedaliero-Universitaria di Padova
Padova, Italy
Ospedale di Circolo e Fondazione Macchi
Varese, Italy
Amsterdam UMC Research BV
Amsterdam, Netherlands
Franciscus
Rotterdam, Netherlands
Hospital General Universitario de Alicante
Alicante, Spain
Greater Glasgow Health Board
Glasgow, United Kingdom