Evaluation of WeFlow-EndoSeal Aorta Vascular Plug System with TEVAR Compared to Standard TEVAR for Stanford Type B Aortic Dissection

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the WeFlow-EndoSeal Aorta Vascular Plug System combined with thoracic endovascular aortic repair TEVAR in people diagnosed with Stanford type B aortic dissection. The study aims to determine if adding the WeFlow-EndoSeal device to standard TEVAR improves treatment outcomes without increasing safety risks. Participants will be randomly assigned to receive either the combined treatment or standard TEVAR alone. Participants in the test group will receive the WeFlow-EndoSeal Aorta Vascular Plug System along with TEVAR, while the control group will undergo standard TEVAR treatment based on current guidelines. Both groups will have their procedures performed according to the assigned treatment method. Follow-up includes clinical and imaging assessments to monitor the efficacy and safety of the treatments over time. Participants will complete scheduled clinical follow-ups and imaging tests at various times after the procedure, including assessments of the aortas condition, device performance, and any adverse events. The main outcomes measured are the clinical success rate at 12 months and the occurrence of major adverse events within 30 days after surgery. Secondary measures include technical success during the procedure, changes in aortic size and false lumen thrombosis, device migration, need for additional surgery, and mortality rates, followed up to 5 years postoperatively.

WeFlow-EndoSeal™ Aorta Vascular Plug System for the Treatment of Stanford Type B Aortic Dissection