VBX 24-03 GORE VIABAHN
Research type
Research Study
Full title
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
IRAS ID
353775
Contact name
Martin Hennessy
Contact email
Sponsor organisation
W.L. Gore and Associates Inc.
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
This multicenter, single-arm, and retrospective clinical study is being conducted to evaluate the safety and effectiveness of GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (“VBX Device” or also referred to as “VBX Stent Graft”) when used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to treat Aortoiliac Occlusive Disease (AIOD).
A minimum of 20 sites and a maximum of 35 sites from the United States and Europe will participate in the study.
Patients are enrolled into the study when they provide consent or consent is waived and meet all inclusion and exclusion criteria.
Subjects’ medical records will be reviewed by the site and specific data will be collected retrospectively from the index procedure through last date of contact or enrollment date.
The study is meant to retrospectively collect data for reporting as well as evaluate “real world” experience of clinical practice and patient outcomes during treatment and through available study follow-up.
REC name
London - Stanmore Research Ethics Committee
REC reference
25/PR/0441
Date of REC Opinion
28 May 2025
REC opinion
Further Information Favourable Opinion