Triple-branched stent graft system for aortic arch lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single‑arm interventional study evaluating the Triple Branched Covered Stent Graft System for aortic arch lesions (aneurysms and ulcers). Participants undergo endovascular implantation and are followed at pre‑discharge, 30 days, 6 months, and 12 months to assess safety and efficacy against predefined targets. The study uses predefined primary endpoints to determine treatment success at 12 months and MAE rates at 30 days. Eligibility focuses on adults with specific anatomical criteria making them high risk for open surgery. Investigators screen candidates and ensure proper follow‑up as part of the protocol.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• Shanghai Changhai Hospital, Naval Medical University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Qingsheng Lu, Dr. — Changhai Hospital
• Study coordinator: Qingsheng Lu, Dr.
• Email: luqs@newvascular.cn
• Phone: +8613917292504

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GORE TBE Device in Zone 0/1 for Aortic Arch Conditions

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• Arcevo LSA stent graft for repairing aortic arch dissections and aneurysms

  This trial will test whether the Arcevo LSA stent graft can safely and effectively repair aortic arch and descending thoracic aortic dissections or aneurysms in adults.

  Recruiting at 26 sites Artivion Inc. · Birmingham, Alabama and 25 other locations · NCT07089576

• Endovascular treatment for aortic arch diseases using a new stent-graft system

  This study is testing a new stent-graft system to see if it can safely and effectively treat aortic arch diseases like aneurysms and ulcers in patients aged 18 to 80.

  Recruiting at 16 sites Lifetech Scientific (Shenzhen) Co., Ltd. · Beijing and 16 other locations · NCT06520774

• A study on a new stent graft system for aortic arch aneurysms

  This study is testing a new stent graft system to see if it can safely and effectively treat aortic arch aneurysms in patients.

  Recruiting at 20 sites Hangzhou Endonom Medtech Co., Ltd. · Beijing and 19 other locations · NCT06385379

• Collecting data on custom-made stent-graft devices for aortic treatment

  This study is testing how safe and effective custom-made stent-grafts are for treating complex aortic conditions in real-world settings.

  Recruiting at 18 sites Cook Group Incorporated · Aarhus, Denmark and 17 other locations · NCT05896397

• Evaluating a new stentgraft for aortic arch conditions

  This study is testing a new type of stent for people with aortic arch problems to see how well it works and how safe it is.

  Recruiting University Hospital Muenster · Münster · NCT05530304

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.