Registry of Physician-Modified Valiant Captivia Endograft for Complex Abdominal and Thoracoabdominal Aortic Aneurysms

What this Trial Is About

Researchers are evaluating a standardized physician-modified fenestrated endograft PMEG approach for treating complex abdominal aortic aneurysms AAA and thoracoabdominal aortic aneurysms TAAA where standard endovascular repair is not suitable due to anatomy. This observational study focuses on patients treated with the Valiant Captivia thoracic endograft, modified by physicians to incorporate fenestrations for target vessels. The goal is to assess the safety and feasibility of this standardized modification technique compared to other treatments, particularly for urgent or symptomatic aneurysms. The treatment involves modifying a standard Valiant Captivia thoracic graft on a sterile back-table in a hybrid operating room. The graft is partially deployed, and fenestrations are created using cautery and reinforced with sutures and guidewire tips. A posterior constraining wire is added to reduce graft diameter temporarily, allowing rotation during deployment. Markers are adjusted for orientation, and the graft is re-sheathed before implantation. All patients in the study receive this 4-fenestrated PMEG endograft. Participants undergo a postoperative CT angiography within 30 days to assess technical success and early outcomes. Follow-up imaging is recommended at 6, 12, and 24 months, then yearly, to monitor freedom from target vessel and endograft instability and aneurysm sac changes over five years. The study includes evaluations of major adverse events and long-term device performance. Participant involvement consists of treatment, imaging assessments, and clinical monitoring over an extended period.

Standardized Physician-modified Fenestrated Endograft Registry