NCT07067840

Triple Branched Stent Graft System for Aortic Arch Lesions

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Treated with the triple branched stent graft system	Participants treated with the triple branched stent graft system

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-12-31
• Completion: 2030-12-31
• First posted: 2025-07-16
• Last updated: 2025-07-16

Locations

1 site across 1 country: China