Guo's Aortic Arch Reconstruction :The Prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System (GIANT Study)

Inclusion Criteria:

1. Patients aged 18 to 80 years old;
2. Diagnosed with aortic arch lesions requiring intervention, including true aortic archaneurysms, 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;
• Innominate artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
• Left common carotid artery or left subclavian artery diameter ≤ 24 mm and ≥ 7 mm,length ≥ 20 mm；
• Suitable arterial access for endovascular interventional treatment;

4. Able to understand the purpose of the trial, participate in the trial voluntarily withinformed 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. Evaluated by at least two vascular surgeons or cardiac surgeons as high surgical riskpatients or deemed to have significant surgical contraindications.

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 carotid or subclavianartery;
6. Heart transplant;
7. Suffered MI or stroke during past three months;
8. Class IV heart function (NYHA classification);
9. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previousthree months;
10. Hematological abnormality, defined as follows: Leukopenia (WBC < 3 × 109/L), acuteanemia (Hb < 90 g/L); thrombocytopenia (PLT count < 50 × 109/L), history of bleedingor coagulopathy;
11. Renal insufficiency， creatinine > 265 umol/L (or 3.0mg/dL) and/or end-stage renaldisease requiring renal dialysis, as determined by an investigator after a thoroughanalysis;
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.