Concave Supra-arch Branched Stent-Graft System for Treatment of Aortic Arch Diseases

Inclusion Criteria:

1. Patients who are ≥ 18 years old and ≤ 85 years old；
2. Patients with aortic arch diseases (involving aortic arch aneurysm, aortic dissection,aortic pseudoaneurysm, aortic ulcer, and intermural hematoma);
3. Anatomical criteria, including:
4. Ascending aorta length is greater than or equal to 50 mm (distance from aorticsinus to anterior edge of innominate artery);
5. The diameter range of the anchoring area at the proximal end of the main body isbetween 25-45 mm and the length is greater than or equal to 15 mm;
6. The diameter of the anchored area of the innominate artery is between 10-16 mm,the diameter of the anchored area of the left common carotid artery is between 5-12 mm, and the diameter of the anchored area of the left subclavian artery isbetween 5-12 mm. Anchorage zone length is greater than or equal to 15 mm;
7. Distance between the anterior edge of the innominate artery to the posterior edgeof the left subclavian artery is less than or equal to 80 mm;
8. Have a suitable iliac, femoral, and superior arch arterial approach;
9. Patients who understand the purpose of the study, volunteer to participate and signthe informed consent form, and are willing to complete follow-up visits as required bythe protocol.

Exclusion Criteria:

1. Patients with general or local infections that may increase the risk of endovasculargraft infection;
2. Patients with severe stenosis, calcification, or mural thrombus in the stent anchoringarea, which is likely to make the stent-graft difficult to adhere to or affect thepatency of the stent;
3. Patients with neck vascular surgery within 3 months;
4. Patients with severe carotid or subclavian artery stenosis, calcification;
5. Patients with a history of acute coronary syndrome within 6 months: Acute coronary syndromes are cardiac acute ischemic syndromes resulting from ruptureof an unstable atherosclerotic plaque in the coronary artery or erosion secondary tothe formation of new blood 4 thrombus, including ST-elevation myocardial infarction,non-ST elevation myocardial infarction, and unstable angina.
6. Patients with transient ischemic attack (TIA) or ischemic stroke within 3 months;
7. Patients with preoperative hepatic and renal dysfunction, [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeded the upper limit of normal level bya factor of five; Serum creatinine (Cr) >150umol/L];
8. Patients with history of bleeding or coagulopathy, who cannot receive antiplatelettherapy;
9. Patients with severe aortic insufficiency or a history of prior aortic valveinsufficiency treatment;
10. Patients with a history of hypersensitivity to contrast agents, anticoagulantantiplatelet agents, stents, delivery equipment materials (i.e., nitinol, polyester,PTFE, nylon polymer materials);
11. Patients with connective tissue diseases such as Marfan's syndrome, Egyptian syndrome,or Behcet's disease;
12. Patients with arteritis;
13. Patients with significant organ dysfunction or other serious disease;
14. Patients with life expectancy of not more than 1 year;
15. Patients who are not eligible for endovascular treatment per in the investigator'sjudgment of the investigator;
16. Women with planned pregnancy, pregnancy stage , or lactation
17. The patient participated in another clinical trial and was not out or withdrawn withinthe first 3 months of the screening period of this study.