Study of Physician-Modified Fenestrated and Branched Stent Grafts to Treat Thoracoabdominal and Complex Abdominal Aortic Aneurysms and the Impact of Frailty on Outcomes

What this Trial Is About

Researchers are evaluating the use of physician-modified fenestrated and branched endografts to treat thoracoabdominal and complex abdominal aortic aneurysms in patients who are at high risk for open surgical repairs. This single-arm, prospective feasibility study aims to assess the safety and early effectiveness of these modified devices immediately after treatment, at 30 days, and up to 5 years. Additionally, the study will examine how patient frailty before and after aneurysm repair relates to clinical outcomes to better identify patients at higher risk of poor results or functional decline. The study involves modifying commercially approved thoracic aortic stent-grafts, specifically the Cook Zenith Alpha and TX2 models, using a patient-specific plan based on 3-D CT angiography analysis. Modifications include creating fenestrations and branch cuffs to incorporate visceral and renal branches, with techniques involving unsheathing, wire rerouting, cautery, suturing, and radiopaque marker placement. The modified stent grafts are prepared on the day of surgery and then implanted as the treatment for the aneurysms. Participants will undergo assessments before and after the procedure, including monitoring for major adverse events up to 30 days post-surgery and evaluating technical and treatment success at multiple time points up to 5 years. Researchers will track the impact of frailty on outcomes and functional status over time. Follow-up visits will assess safety and effectiveness through clinical evaluations and imaging, with the overall participation lasting up to five years after treatment.

Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies