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

Recruiting now · Not applicable

Conditions studied: Aortic Arch Aneurysm

In brief

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)

Key facts

Study ID

NCT06385379

Run by

Hangzhou Endonom Medtech Co., Ltd.

People needed

90

Starts

2024-06-30

Expected to finish

2030-12-31

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 18 to 80 years old;
• Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch;
• 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;
• 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.
• 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.

You may not qualify if…

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

Where it is running

• Beijing Anzhen Hospital, Capital Medical University — Beijing, China (enrolling)
• Chinese PLA Gencral Hosptial — Beijing, China (enrolling)
• The First Hospital of Jilin University — Changchun, China (enrolling)
• Xiangya Hospital of Central South University — Changsha, China (enrolling)
• West China Hospital of Sichuan University — Chengdu, China (enrolling)
• Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou, China (enrolling)
• The First Affiliated Hospital ,Sun Yat-sen University — Guangzhou, China (enrolling)
• The First Affiliated Hospital of Harbin Medical University — Harbin, China (enrolling)
• Shandong Provincial Hospital — Jinan, China (enrolling)
• The First People's Hospital of Yunnan Province — Kunming, China (enrolling)
• The Second Affiliated Hospital Of Nanchang University — Nanchang, China (enrolling)
• Nanjing First Hospital — Nanjing, China (enrolling)
• The First Affiliated Hospital of Nanjing Medical University — Nanjing, China (enrolling)
• The Affiliated Hospital Of Qingdao University — Qingdao, China (enrolling)
• Shanghai Chest Hospital — Shanghai, China (enrolling)
• Zhongshan Hospital, Fudan University — Shanghai, China (enrolling)
• The First Affiliated Hospital of China Medical University — Shenyang, China (enrolling)
• The First Affiliated Hospital of PLA Air Force Military Medical University — Xi'an, China (enrolling)
• Xiamen Cardiovascular Hospital — Xiamen, China (enrolling)
• First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (enrolling)

Full record on ClinicalTrials.gov

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