AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingNAAges 18 Years - 80 YearsAllHangzhou Endonom Medtech Co., Ltd.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 24 mm and โ‰ค 48 mm; * Proximal anchoring zone length โ‰ฅ 30 mm; * Branch arteries to be reconstructed were โ‰ค 24 mm and โ‰ฅ 6 mm in diameter and โ‰ฅ 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 ร—109/L), acute anemia (Hb \< 90 g/L), Coagulation disorders, thrombocytopenia (PLT count \< 50 ร— 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.
๐Ÿ’Š

What it tests

  • WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system
๐Ÿ“

Where

20 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Chinese PLA Gencral Hosptial
Beijing, China
The First Hospital of Jilin University
Changchun, China
Xiangya Hospital of Central South University
Changsha, China
West China Hospital of Sichuan University
Chengdu, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, China
The First Affiliated Hospital ,Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital of Harbin Medical University
Harbin, China

โ€ฆand 12 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy