Safety and Effectiveness of a Triple-branched Stent Graft for Arch Repair During Open Acute Debakey Type I Dissection Surgery - a Randomized Controlled Multicenter Clinical Trial

What this Trial Is About

This research aims to evaluate the effectiveness and safety of a new intraoperative stent system for treating acute type I aortic dissection, a serious condition where the inner layer of the aorta tears, causing life-threatening complications. This type involves the ascending aorta, aortic arch, and the entire aorta, and surgery is currently the only treatment option. The study compares this new stent system with the existing Frozen Elephant Trunk Technique to improve long-term outcomes by better reconstructing the aortic arch and preventing complications from residual false lumens. The study involves two groups: one receiving the new triple-branched stent graft implanted directly into the aortic arch and its branches during surgery, and the other undergoing the standard procedure of ascending aorta and arch replacement with the Frozen Elephant Trunk stent placed in the descending thoracic aorta. The new stent system aims to simplify surgery by reducing the need for multiple anastomoses and shortening the time of cerebral and lower body ischemia. Participants will be closely monitored through various assessments during and after surgery, including mortality within 30 days as the primary outcome. Secondary outcomes include death related to aortic dissection within 12 months, thrombosis of the false lumen, and technical success of the procedure. Follow-up will last up to one year to evaluate safety and effectiveness. The total study duration for each participant depends on surgical and follow-up schedules, with careful data collection at multiple time points.

A Triple-branched Stent Graft for Aute Debakey Type I Dissection Surgery