W.L.Gore & Associates
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.
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 i…
Treatment of Target Lesions with the VBX Device in the aortic and common iliac positions during the CERAB procedure.