B-SAFER Study Safety and Feasibility of a Hybrid Stented Repair for Thoracic Aortic Diseases Involving Multiple Aortic Segments

What this Trial Is About

Researchers are evaluating the safety and early effectiveness of a new surgical technique called Branched Stented Anastomosis Frozen Elephant Trunk Repair B-SAFER for treating complex thoracic aortic diseases. This technique uses a specially modified endovascular stentgraft to repair multiple damaged areas of the aorta, particularly where the aortic arch is involved. The study aims to assess how well this hybrid repair method works and how safe it is for patients with conditions like thoracic aortic aneurysm, aortic dissection, or congenital aortic anomalies. The treatment involves implanting a physician-modified endovascular stentgraft designed for the proximal aorta. This simplified hybrid frozen elephant trunk repair technique is performed as part of the surgical procedure. The study focuses on device performance, including the functionality of multiple components used during the operation. Participants will undergo this device implantation as the experimental intervention. During the study, participants will be closely monitored for outcomes such as survival, stroke, paralysis, and technical success shortly after treatment. Follow-up assessments will include checking the patency and sealing of the graft components at hospital discharge or one month. Longer-term monitoring up to three years will evaluate complications like device failures, re-operations, infections, and other adverse events. This comprehensive follow-up helps to understand both the safety and durability of the B-SAFER repair over time.

B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair