Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografts for Treating Thoracoabdominal Aortic Aneurysms in Adults Aged 50 to 95

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for treating thoracoabdominal aortic aneurysms TAAAs. This study compares the use of a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft to previously published results of open surgical replacement of the aneurysmal aorta. The purpose is to demonstrate both safety and effectiveness in adult patients who meet traditional size criteria for surgical repair. The study includes two groups one using the physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for asymptomatic, non-ruptured TAAAs meeting traditional size criteria, and an expanded access group that also includes thoracic or abdominal aortic aneurysms with similar criteria. The device is used endovascularly to treat aneurysms of any Crawford extent I-V. Patients are followed for five years after the procedure. Participants will undergo multiple assessments including survival rates, major adverse events, treatment and technical success at various time points up to five years. Monitoring includes evaluation of complications such as aneurysm rupture, access site issues, neurological events, and conversion to open repair. The study collects data on treatment outcomes and safety, with follow-up visits scheduled for up to five years post-procedure.

Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA