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

This study is a prospective ,multiple center study about the safety and efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System , it is expected to complete the implantation of 90 patients in 20 centers within 20 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24th month, 36th month, 48th month and 60th month postoperatively.

Inclusion criteria

• 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.

Exclusion criteria

• 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.