Triple Branched Stent Graft System for Aortic Arch Lesions

Launched by CHANGHAI HOSPITAL · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medical device called the Triple Branched Covered Stent Graft System, which is designed to treat problems in a large blood vessel near the heart called the aortic arch. These problems include bulges (aneurysms), false bulges (pseudoaneurysms), and ulcers in the aortic arch. The study aims to find out how safe and effective this device is, especially looking at how well it works over a year and whether serious complications occur within the first month after treatment.

People who might be eligible to join are adults aged 18 to 80 who have these specific aortic arch problems and are considered high-risk for traditional open-heart surgery. Participants will receive the stent graft treatment and will have follow-up visits before leaving the hospital, then at 30 days, 6 months, 12 months, and yearly for up to five years. These visits include scans and health check-ups to see how well the device is working and to monitor for any side effects or changes in health. The trial excludes certain groups, like pregnant women, people with specific other health conditions, or those who have had similar treatments before. Overall, this study is important because it explores a less invasive option for treating serious aortic arch conditions in patients who may not be good candidates for open surgery.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria：
• • 1. Patients aged 18-80 years.
• • 2. Diagnosed with aortic arch lesions that require treatment, including true aortic arch aneurysms, false aortic arch aneurysms, and aortic arch ulcers.
• • 3. The investigator determines that the subject is suitable for endovascular therapy.
• • 4. The subject understands the purpose of the trial, voluntarily agrees to participate, and is willing to undergo follow-up.
• 5. Anatomical conditions:
• • Ascending aorta length ≥50 mm.
• • Ascending aorta diameter ≥26 mm and ≤46 mm.
• • Proximal landing zone length ≥20 mm.
• • Brachiocephalic artery diameter ≤19 mm and ≥9 mm, with a length ≥20 mm.
• • Left common carotid artery and left subclavian artery diameter ≤13 mm and ≥5 mm, with a left common carotid artery length ≥20 mm, and the distance from the left vertebral artery opening to the left subclavian artery opening on the aorta ≥20 mm.
• • 6. The investigator assesses the subject as a high-risk patient for open surgery or with significant contraindications to open surgery.
• • Exclusion Criteria
• • 1. Pregnant or breastfeeding women.
• • 2. Patients diagnosed with connective tissue diseases related to the aorta (e.g., Marfan syndrome).
• • 3. Infectious aortic diseases or Takayasu arteritis.
• • 4. Patients who have undergone endovascular treatment of the ascending aorta or aortic arch.
• • 5. Patients with a known allergy to nickel-titanium alloy, contrast agents, or other relevant materials.
• • 6. Severe renal failure (creatinine levels more than twice the upper limit of normal; dialysis patients are excluded).
• 7. Hematological abnormalities:
• • Leukopenia (WBC \< 3×10⁹/L).
• • Anemia (Hb \< 70 g/L).
• • Coagulation disorders: thrombocytopenia (PLT count \< 50×10⁹/L).
• • 8. Heart transplant recipients.
• • 9. History of myocardial infarction or stroke within the past 3 months.
• • 10. Heart function class IV (NYHA classification).
• • 11. Active infections, such as bacteremia or sepsis.
• • 12. Patients with an expected survival of less than 12 months.
• • 13. Patients with aortic valve replacement with a mechanical valve that would interfere with the safe introduction of the trial device.
• • 14. Subjects participating in other drug or medical device clinical trials and have not yet completed the primary endpoints of those trials.
• • 15. Poor compliance, with an expectation of inability to attend follow-up visits.
• • 16. Other conditions deemed by the investigator as unsuitable for endovascular therapy, such as severe vascular stenosis, calcification, tortuosity, thrombosis, or inability to cooperate.