Real-World Data Collection of Gore® Viabahn® VBX Balloon Expandable Endoprosthesis Used in CERAB to Treat AIOD
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 bifur...
About This Study
Summary
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.
To be included in VBX, participants must be / have
- 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)
To be included in VBX, participants must not be / have
- 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
For More About This Study or To Ask About Participation
Additional Information
Lead scientist at Carilion Clinic
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.
Official title of study
Real-World Data Collection of Gore® Viabahn® VBX Balloon Expandable Endoprosthesis Used in CERAB to Treat AIOD