A Multicenter Study on Safety and Effectiveness of the WeFlow-Tribranch Triple-branch Arch Stent Graft System for Treating Aortic Arch Aneurysms

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System for treating true or pseudo aortic arch aneurysms and ulcers involving the aortic arch. This multicenter, prospective study aims to enroll 90 patients across 20 centers to assess outcomes related to this device. The study focuses on patients with aortic arch lesions who are at high surgical risk or have significant surgical contraindications. Participants will receive the WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system, which includes components for the ascending aorta, arch aorta, aortic extension, and branch stents. The treatment involves implanting this device to manage aneurysms or ulcers in the aortic arch. The study includes initial implantation followed by scheduled follow-ups at discharge, 30 days, 6 months, and 12 months after surgery, with long-term monitoring continuing at 24, 36, 48, and 60 months post-operation. During the study, participants will undergo assessments to monitor mortality, stroke rates, technical success, aneurysm progression, device positioning, vessel patency, and adverse events. These evaluations occur at multiple time points after surgery to ensure comprehensive safety and efficacy data collection. The total participation duration may extend up to five years, including both short-term and long-term follow-up visits to track outcomes and device performance.

Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)