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Clinical Trial

Triple Branched Stent Graft System for Aortic Arch Lesions

NCT: NCT07067840 · RECRUITING

NCT IDNCT07067840
StatusRECRUITING
Start Date2025-11-03
Completion2030-12-31
SponsorChanghai Hospital (OTHER)
First posted
Last updated

Brief 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 Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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