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

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 study evaluates the safety and efficacy of the WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System for treating true and pseudo aortic arch aneurysms and ulcers. Conducted across 20 centers, it aims to implant the device in 90 patients over 20 months, with follow-up assessments at various intervals including before discharge, 30 days, 6 months, 12 months, and long-term at 24, 36, 48, and 60 months post-surgery. The study will provide valuable data on the device's performance and patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients aged 18 to 80 years old;
2. Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch;
3. Showing a suitable vascular condition, including:

   * Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
   * Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;
   * Proximal anchoring zone length ≥ 30 mm;
   * Branch arteries to be reconstructed were ≤ 24 mm and ≥ 6 mm in diameter and ≥ 20 mm in length;
   * Suitable arterial access for endovascular interventional treatment;
4. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
5. Subjects were assessed as high risk for surgery by at least two investigators or judged to have significant surgical contraindications. Recommended reference criteria were a European system for cardiac operative risk evaluation (EuroScore) score of 6 or higher or other surgical risk factors as judged by the physician team.

Exclusion Criteria:

1. Experienced systemic infection during past three months;
2. Neck surgery was performed within 3 months;
3. Previous endovascular interventional treatment involving the aortic arch was performed;
4. Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases );
5. Severe stenosis, calcification, thrombosis, or tortuosity of the branch artery to be reconstructed;
6. Heart transplant;
7. Suffered Myocardial Infarction or Stroke during past three months;
8. Class IV heart function (NYHA classification);
9. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;
10. Hematological abnormality, defined as follows: Leukopenia (WBC \< 3 ×109/L), acute anemia (Hb \< 90 g/L), Coagulation disorders, thrombocytopenia (PLT count \< 50 × 109/L);
11. Renal insufficiency, creatinine \> 150 umol/L and/or end-stage renal disease requiring renal dialysis;
12. Pregnant or breastfeeding;
13. Allergies to contrast agents;
14. Life expectancy of less than 12 months;
15. Participating in another drug or device research;
16. Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.

Where it's running

• Beijing Anzhen Hospital, Capital Medical University
  Beijing, China Recruiting
• Chinese PLA Gencral Hosptial
  Beijing, China Recruiting
• The First Hospital of Jilin University
  Changchun, China Recruiting
• Xiangya Hospital of Central South University
  Changsha, China Recruiting
• West China Hospital of Sichuan University
  Chengdu, China Recruiting
• Guangdong Provincial Hospital of Traditional Chinese Medicine
  Guangzhou, China Recruiting

Study contacts

• Study coordinator: Wei Guo
• Email: Pla301dml@vip.sina.com
• Phone: 13910758706

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

  This study tests the GORE TAG Thoracic Branch Endoprosthesis in adults with aortic arch problems in Zone 0 or 1 to see how it performs over several years in routine care.

  Recruiting at 24 sites W.L.Gore & Associates · Scottsdale, Arizona and 23 other locations · NCT07166133

• 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

• Triple-branched stent graft system for aortic arch lesions

  This trial tests whether the triple branched covered stent graft can safely treat aortic arch lesions and achieve a high 12‑month treatment success with a low 30‑day major adverse events in adults.

  Recruiting Changhai Hospital · Shanghai, Shanghai Municipality · NCT07067840

• 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

• 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.