Triple Branched Stent Graft System for Aortic Arch Lesions

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChanghai Hospital

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

96 Participants
are divided into 1 treatment group

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