Triple Branched Stent Graft System for Aortic Arch Lesions (NCT07067840) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Triple Branched Stent Graft System for Aortic Arch Lesions
China96 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
✓. The subject understands the purpose of the trial, voluntarily agrees to participate, and is willing to undergo follow-up.
✓. Anatomical conditions:
✓. The investigator assesses the subject as a high-risk patient for open surgery or with significant contraindications to open surgery.
Exclusion criteria
✕. Pregnant or breastfeeding women.
✕. Patients diagnosed with connective tissue diseases related to the aorta (e.g., Marfan syndrome).
✕. Infectious aortic diseases or Takayasu arteritis.