Overview
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).
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
Inclusion Criteria:
- Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD).
- Patient was implanted with the VBX Device in the aortic position during a CERAB procedure.
- Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date.
- Age ≥18 years at the time of CERAB procedure.
- Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC) -
Exclusion Criteria:
- Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure.
- Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery).
- Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints.
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