About this trial
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.
Eligibility criteria
Qualifiers
:
Patients aged 18-80 years.
Diagnosed with aortic arch lesions that require treatment, including true aortic arch aneurysms, false aortic arch aneurysms, and aortic arch ulcers.
The investigator determines that the subject is suitable for endovascular therapy.
Disqualifiers
Pregnant or breastfeeding women.
Patients diagnosed with connective tissue diseases related to the aorta (e.g., Marfan syndrome).
Infectious aortic diseases or Takayasu arteritis.
Patients who have undergone endovascular treatment of the ascending aorta or aortic arch.
Trial design
Treatments tested in this trial
- Treated with the triple branched stent graft system
Treatment groups
Sponsors and collaborators
Changhai Hospital
Lead sponsor
Zhongnan Hospital
Collaborator
The University of HongKong-Shenzhen Hospital
Collaborator
West China Hospital
Collaborator
Meizhou People's Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
The Third Affiliated Hospital of Wenzhou Medical University
Collaborator
The First Affiliated Hospital of University of South China
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
Guangyuan Central Hospital
Collaborator
Jining First People's Hospital
Collaborator
The First People's Hospital of Yunnan
Collaborator
Dalian Municipal Central Hospital
Collaborator
Tianjin Chest Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
The Affiliated Hospital Of Southwest Medical University
Collaborator
Kunming Yan'an Hospital
Collaborator