Study of Zenith Fenestrated Endovascular Graft with BeGraft and Unibody2 Devices for Treating Aortic Aneurysms Involving Major Visceral Arteries

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Zenith4 Fenestrated Endovascular Graft ZFEN combined with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2 device for treating patients with aortic aneurysms affecting one or more major visceral arteries. The study focuses on patients with thoracoabdominal, pararenal, or juxtarenal aortic aneurysms. This clinical investigation aims to assess procedural success, safety, and patient outcomes using this combination device approach. Participants will receive the Zenith4 Fenestrated Endovascular Graft along with the BeGraft system and Unibody2 in an endovascular aneurysm repair procedure. The study includes an initial treatment phase followed by a Continued Access phase that may enroll up to 60 additional subjects. This approach allows evaluation of the device combination in a real-world setting for patients with complex aortic aneurysms. During the study, patients will be monitored for device technical success and procedural safety within 30 days post-procedure. Longer-term outcomes include freedom from aneurysm-related death and significant reintervention at 12 months after treatment. Follow-up involves clinical assessments and imaging to track aneurysm condition and device performance. Participants are expected to comply with scheduled visits and evaluations throughout the study duration, which extends to at least one year post-procedure.

Zenith® Fenestrated+ Clinical Study