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Recruiting Not applicable

Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)

NCT06385379 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-06-30
Last updated
2026-05-01

Condition(s) studied

Aortic Arch Aneurysm

Investigational drug(s) / intervention(s)

WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system

WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system: The WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system, the aortic extension stent graft system and the branch stent system.

Study summary

A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study)

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Rate of all-cause mortality and major stroke within 12 months after surgery — 12 months after surgery
    All-cause mortality includes cardiac mortality, non-cardiac mortality, and mortality from unknown causes. Severe stroke is defined as a modified Rankin score (mRS) ≥ 2 at 90 days following stroke onset.

Trial sites (20)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06385379 on ClinicalTrials.gov ↗ ← All trials in China