Effectiveness and Safety of a Type A Dissection Total Endovascular Reconstruction System in Promoting Favorable Distal Aortic Remodeling

Exclusion Criteria

• •1. Presence of a proximal anastomotic leak at the frozen elephant trunk site post open surgery.
• •2. No left subclavian artery revascularization during the open surgery.
• •3. Presence of severe endoleak, or residual dissection expansion ≥55mm, or distal stent graft-induced new entry.
• •4. History of myocardial infarction, or stroke (with clear symptoms/signs and culprit lesion), or bowel ischemia within 1 month prior to the procedure.
• •5. Previous history of descending thoracic or abdominal aortic surgery.
• •6. Lack of suitable vascular access.
• •7. Known allergy to components of the study device (e.g., Nitinol) or contrast agent.
• •8. Renal insufficiency (creatinine \>2.5 times the upper limit of normal) or requiring long-term regular dialysis.
• •9. Severe liver dysfunction (Child-Pugh Class C).
• •10. Active bleeding, coagulation disorders, thrombocytopenia (platelet count \<50×109/L), or refusal of blood transfusion.
• •11. Uncontrolled severe infection and associated sepsis, shock, or multiple organ failure.
• •12. Life expectancy less than 12 months (due to conditions other than aortic dissection).
• •13. Known or suspected connective tissue degenerative disease, or family history of aortic dissection.
• •14. Pregnant or lactating women.
• •15. Concurrent participation in other drug or medical device clinical studies.
• •16. Subjects deemed unsuitable for participating the study by the investigator.