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

Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch Unique Embedded Aortic Triple-branch Arch Stent Graft System (GENIUS Study)

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

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Hangzhou Endonom Medtech Co., Ltd. (Industry-sponsored)
• Locations: 20 sites (Beijing and 19 other locations)
• Trial ID: NCT06385379 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with aortic arch lesions requiring intervention and suitable vascular conditions.

Not a fit: Patients with aortic arch lesions that do not meet the specified criteria or those who are not considered high risk for surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new, effective treatment option for patients with aortic arch aneurysms, potentially improving survival rates and quality of life.

How similar studies have performed: While this approach is novel, similar studies involving advanced stent graft systems have shown promising results in treating vascular conditions.

Eligibility criteria

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 this trial is running

Beijing and 19 other locations

• 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)
• The First Affiliated Hospital ,Sun Yat-sen University — Guangzhou, China (Recruiting)
• The First Affiliated Hospital of Harbin Medical University — Harbin, China (Recruiting)
• Shandong Provincial Hospital — Jinan, China (Recruiting)
• The First People's Hospital of Yunnan Province — Kunming, China (Recruiting)
• The Second Affiliated Hospital Of Nanchang University — Nanchang, China (Recruiting)
• Nanjing First Hospital — Nanjing, China (Recruiting)
• The First Affiliated Hospital of Nanjing Medical University — Nanjing, China (Recruiting)
• The Affiliated Hospital Of Qingdao University — Qingdao, China (Recruiting)
• Shanghai Chest Hospital — Shanghai, China (Recruiting)
• Zhongshan Hospital, Fudan University — Shanghai, China (Recruiting)
• The First Affiliated Hospital of China Medical University — Shenyang, China (Recruiting)
• The First Affiliated Hospital of PLA Air Force Military Medical University — Xi'an, China (Recruiting)
• Xiamen Cardiovascular Hospital — Xiamen, China (Recruiting)
• First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (Recruiting)

Study contacts

• Study coordinator: Wei Guo

Conditions Aortic Arch Aneurysm