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

Inclusion Criteria:

1. Patients aged 18 to 80 years old;

2. Diagnosed with aortic arch lesions requiring intervention, including true aorticarch 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 tothe 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 voluntarilywith informed consent form signed by the patient him/herself or his or her legalrepresentative, and willing to complete follow-up visits as required under theprotocol.

5. Subjects were assessed as high risk for surgery by at least two investigators orjudged to have significant surgical contraindications. Recommended referencecriteria 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 wasperformed;

4. Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connectivetissue diseases );

5. Severe stenosis, calcification, thrombosis, or tortuosity of the branch artery to bereconstructed;

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 theprevious three months;

10. Hematological abnormality, defined as follows: Leukopenia (WBC < 3 ×109/L), acuteanemia (Hb < 90 g/L), Coagulation disorders, thrombocytopenia (PLT count < 50 × 109/L);

11. Renal insufficiency, creatinine > 150 umol/L and/or end-stage renal diseaserequiring 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 hinderendovascular interventional treatment.