Evaluation of TUVA BX and iCover Stent Grafts in Minimally Invasive Repair of Complex Aortic Aneurysms

What this Trial Is About

Researchers are evaluating the safety and performance of the TUVA BX and iCover stent graft devices used during branched endovascular aortic repair BEVAR, a minimally invasive surgery for treating complex aortic aneurysms such as thoracoabdominal aortic aneurysms TAAA and complex abdominal aortic aneurysms AAA. This retrospective observational study collects data from multiple hospitals in Europe, the UK, and Switzerland without comparing to other groups. The study focuses on patients who have already undergone the BEVAR procedure using the TUVA BX or iCover stent grafts as bridging devices in the repair. Researchers will review medical records starting from the original surgery performed after January 2020 and continuing through the one-year follow-up. No new treatments or additional hospital visits are required as part of this study. Participants existing medical information, including details from their initial procedure and follow-up visits, will be analyzed to assess outcomes such as freedom from re-intervention due to device complications, technical success, device patency, mortality, and device separation at one year. The study expects to include about 105 patients and complete data collection by December 2026.

Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)