Outcomes and Safety of Physician-Modified Fenestrated and Branched Stent Grafts for Treating Juxtarenal, Pararenal, and Thoracoabdominal Aortic Aneurysms

What this Trial Is About

Researchers are evaluating the safety and effectiveness of an endovascular treatment for aortic aneurysms located near the kidneys and in the thoracoabdominal region. The study focuses on physician-modified stent grafts that combine fenestrations and branches to treat juxtarenal, pararenal, and thoracoabdominal aortic aneurysms, including those involving the iliac artery. This study aims to understand outcomes and major adverse events in patients receiving these specialized grafts, sponsored by the University of California, Los Angeles. Participants will receive investigational treatment using physician-modified stent grafts such as Cook Alpha TX2, Cook Zenith TX2, and Cook Zenith Fenestrated Stent Graft. These grafts use multiple components with fenestrations andor branches to repair the aneurysms. The study includes three groups based on aneurysm location and urgency those with short neck infrarenal to extent IV thoracoabdominal aneurysms, those with extent I to III thoracoabdominal aneurysms, and those needing urgent or emergency repair within 48 hours. All participants will undergo repair using the investigational grafts. During the study, patients will be monitored for major adverse events within 30 days and treatment success at 12 months. Quality of life will be assessed at baseline, 30 days, 6 months, and then annually for up to 5 years. Follow-up includes clinical evaluations to track health changes and device performance. Participation may last several years, allowing researchers to gather long-term safety and effectiveness data for these physician-modified stent grafts.

Clinical Outcomes and Major Adverse Events in Patients Treated With Physician-Modified Fenestrated and Branched Stent Grafts