Triple Branched Stent Graft System for Aortic Arch Lesions

Summary

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.

Conditions

• Aortic Arch Aneurysm
• Aortic Arch Pseudoaneurysm
• Aortic Arch Ulcer

Interventions

DEVICE

Treated with the triple branched stent graft system

Participants treated with the triple branched stent graft system

Sponsors & Collaborators

• Zhongnan Hospital

  collaborator OTHER

• The University of HongKong-Shenzhen Hospital

  collaborator UNKNOWN

• West China Hospital

  collaborator OTHER

• Meizhou People's Hospital

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• The Third Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• The First Affiliated Hospital of University of South China

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Guangyuan Central Hospital

  collaborator UNKNOWN

• Jining First People's Hospital

  collaborator OTHER

• First People's Hospital of Yunnan Province

  collaborator UNKNOWN

• Dalian Municipal Central Hospital

  collaborator OTHER

• Tianjin Chest Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• The Affiliated Hospital Of Southwest Medical University

  collaborator OTHER

• Kunming Yan'an Hospital

  collaborator UNKNOWN

• Changhai Hospital

  lead OTHER

Principal Investigators

• Qingsheng Lu, Dr. · Changhai Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2026-12-31

Completion

2030-12-31

Countries

• China

Study Locations