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NOT YET RECRUITING
NCT07067840
NA

Triple Branched Stent Graft System for Aortic Arch Lesions

Sponsor: Changhai Hospital

View on ClinicalTrials.gov

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.

Official title: Safety and Efficacy of the Triple Branched Covered Stent Graft System for the Treatment of Aortic Arch Lesions: a Prospective, Multicenter, Single-Arm Trial.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2025-09-01

Completion Date

2030-12-31

Last Updated

2025-07-16

Healthy Volunteers

No

Interventions

DEVICE

Treated with the triple branched stent graft system

Participants treated with the triple branched stent graft system

Locations (1)

Shanghai Changhai Hospital, Naval Medical University

Shanghai, Shanghai Municipality, China