Study of the Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Aneurysms and Penetrating Ulcers in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Lifetech Concave Supra-arch Branched Stent-Graft System for treating aortic arch diseases such as aortic arch aneurysms and penetrating aortic ulcers. This study is designed as a prospective, multicenter, single-group clinical trial to assess this device in patients needing intervention for these conditions, focusing on outcomes related to surgery and long-term vessel health. The study involves the use of the Concave Supra-arch Branched Stent-Graft System for endovascular treatment, where the stent-graft is placed inside the aorta to manage the disease. The procedure targets patients with specific anatomical criteria regarding the aorta and branch vessels. The study includes a detailed monitoring schedule with assessments at surgery, before discharge, and follow-ups at 6 months, 12 months, and up to 5 years to track treatment success and complications. Participants will undergo evaluations including imaging and clinical assessments to monitor technical success, vessel patency, aneurysm size changes, complications like endoleaks or stent migration, adverse events, and mortality related to the aorta and overall health. The study monitors safety closely during the perioperative period and long-term. Participants will be followed for up to five years to assess the outcomes and safety of the device after treatment.

Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases