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).
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.
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.
As described in the background section, patients with aortoiliac occlusive disease are treated with various surgical and endovascular therapies to improve arterial blood flow to the lower extremity. This study will retrospectively evaluate a population of patients that have had covered endovascular reconstruction of the aortic bifurcation (CERAB) with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. The study has been designed with standard eligibility criteria to evaluate the safety and effectiveness of the VBX Device when used in a CERAB for an aortoiliac occlusive disease patient population. Considering the nature of aortoiliac occlusive disease, elderly patients (≥ 65 years old) can represent a significant number of patients enrolled in this study. This population can include patients with cognitive disorder or severe dementia. According to EU regulation, elderly patients are considered vulnerable population. However, considering the retrospective nature of the study design, t
Cohort
Retrospective
GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
DeviceTreatment of Target Lesions with the VBX Device in the aortic and common iliac positions during the CERAB procedure.
Primary Effectiveness Endpoint: 1-Year Primary patency (hypothesis testing)
Proportion of patients maintaining primary patency at 1 Year
Primary Safety Endpoint: 30-day Morbidity (hypothesis testing)
Proportion of patients experiencing any major adverse cardiovascular event (i.e. myocardial infarction, cerebrovascular accident) or event requiring reintervention.
Technical Success
Proportion of patients with technical success
Mortality
Proportion of patients with all cause death
Device Integrity
Proportion of patients achieving Primary Patency
Primary assisted patency
Proportion of patients achieving Primary Assisted patency
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