Evaluation of Physician-Modified Endovascular Grafts for Repairing Juxtarenal Aortic Aneurysms in High-Risk Adults Including Elective, Symptomatic, and Ruptured Cases

What this Trial Is About

This research aims to evaluate the use of Physician-Modified Endovascular Grafts to treat juxtarenal aortic aneurysms in high-risk adults who are not suitable candidates for open surgical repair and have limited treatment options. The study focuses on assessing safety and early effectiveness of the device in patients with appropriate anatomy, including those with elective, symptomatic, or ruptured aneurysms. Participants will receive an implantation of a Physician-Modified Terumo Aortic TREO abdominal stent graft system. This device is modified during the procedure by creating fenestrations to maintain blood flow to vital branch vessels, which are supported by stents. The study will monitor outcomes acutely, at 30 days, 6 months, 12 months, and annually up to 5 years to assess treatment success and device performance. During the study, participants will be closely monitored through scheduled follow-up exams to assess major adverse events, effectiveness, and technical success of the device. Researchers will track safety events, device integrity, aneurysm changes, and any need for additional interventions over a 5-year period. Participants must comply with all required exams and will be observed for long-term outcomes related to the treatment.

Physician Modified Endovascular Grafts for the Treatment of Juxtarenal Aortic Aneurysms