Real-World Data Collection of Gore® Viabahn® VBX Balloon Expandable Endoprosthesis Used in CERAB to Treat AIOD
About
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 and subsequent follow-up visits.
Eligibility Criteria
Inclusion Criteria
- Patient treated with CERAB procedure for AIOD
- Patient was implanted with the VBX Device in the aortic position during a CERAB procedure
- Patient was treated with the CERAB index procedure a minimum of 1 year before enrollment date
- Age ≥18 years at the time of the 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 the CERAB procedure
- Patient treated with concomitant chimney procedure at time of the CERAB procedure (e.g., inferior mesenteric artery, renal artery)
- Participation in another drug or device investigational study at the time of the CERAB procedure
Primary Investigator
Dr. Esmaeel Reza Dadashzadeh is a dual board-certified vascular surgeon with a strong background in both clinical care and research. He’s currently the interim director of the Carilion Clinic Aortic Center and interim section chief of Aortic and Endovascular Surgery. In addition to his clinical roles, he’s an assistant professor of Aortic and Endovascular Surgery at Virginia Tech Carilion School of Medicine.
Dr. Dadashzadeh completed his vascular surgery fellowship at Washington University in St. Louis and his general surgery residency at the University of Pittsburgh Medical Center. He also holds a master’s in biomedical informatics from the University of Pittsburgh.
Contact Information
Yili Zhong, PhD
Clinical Research Coordinator
