Triple Branched Stent Graft System for Aortic Arch Lesions

The goal of this clinical trial is to evaluate the safety and efficacy of the Triple Branched Covered Stent Graft System in treating aortic arch lesions. The main questions it aims to answer are: * Does the Triple Branched Covered Stent Graft System achieve a 12-month treatment success rate that meets or exceeds the predefined target value? * What is the 30-day major adverse event (MAE) rate following the use of the Triple Branched Covered Stent Graft System? Researchers will use a single-arm study design with predefined target values for the primary endpoints to assess the performance of the stent system. Participants will: * Undergo a comprehensive screening process to determine eligibility based on specific inclusion and exclusion criteria. * Receive the Triple Branched Covered Stent Graft System implantation as part of the treatment for their aortic arch lesions. * Attend follow-up visits at specified intervals (e.g., pre-discharge, 30 days post-surgery, 6 months, 12 months, and annually up to 5 years) for evaluations including imaging studies (CTA) and clinical assessments. * Report any adverse events or changes in their health status during the follow-up period.

NCT Number	NCT07067840
Lead Sponsor	Changhai Hospital Collaborators: Zhongnan Hospital, The University of Hong Kong-Shenzhen Hospital, West China Hospital, Meizhou People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, The Third Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of University of South China, First Affiliated Hospital of Chongqing Medical University, Guangyuan Central Hospital, Jining First People's Hospital, The First People's Hospital of Yunnan, Dalian Municipal Central Hospital, Tianjin Chest Hospital, Xiangya Hospital of Central South University, The Affiliated Hospital Of Southwest Medical University, Kunming Yan'an Hospital
Conditions	Aortic Arch Aneurysm, Aortic Arch Pseudoaneurysm, Aortic Arch Ulcer
Enrollment	96 participants
Start Date	2025-09-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-07-16