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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).
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.
Age
18 - 100 years
Sex
ALL
Healthy Volunteers
No
University of California
Fresno, California, 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
Start Date
May 30, 2025
Primary Completion Date
August 16, 2027
Completion Date
August 16, 2027
Last Updated
January 21, 2026
158
ESTIMATED participants
GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
DEVICE
Lead Sponsor
W.L.Gore & Associates
NCT05811364
NCT04148456
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04458714