IRB Study Number 23-1124
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
The primary objective of this study is to evaluate the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) for the treatment of patients with aortic aneurysms, where the device sealing zone requires fenestrations with connections to one or more of the major visceral arteries.
Inclusion Criteria
- Aneurysm diameter 5 mm males
- Aneurysm growth rate of 6 months
- Aneurysm diameter > 2x the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator
Exclusion Criteria
- Age < 18 years
- Life expectancy < 2 years
- Pregnant, breast-feeding, or planning to become pregnant within 60 months
- Marfan syndrome or connective tissue disorder
- Leaking, ruptured, or mycotic aneurysm
- Permanent dialysis, dialysis within 30 days prior to procedure, or chronic kidney
- Stroke or myocardial infarction within 3 months
- Previous endovascular graft in the abdominal or thoracic aorta
