WeFlow-EndoSeal™ Aorta Vascular Plug System for the Treatment of Stanford Type B Aortic Dissection

Exclusion Criteria

• •1. Presence of persistent malperfusion of visceral arterial branches caused by dissection.
• •2. ■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■.
• •3. Infectious aortic disease, Takayasu's arteritis, Marfan syndrome (or other connective tissue diseases).
• •4. Acute systemic infection.
• •5. History of myocardial infarction, TIA, or stroke within the past 3 months.
• •6. NYHA Class IV cardiac dysfunction (see Appendix 1 of the protocol) or LVEF \< 30%.
• •7. Hematologic abnormalities, defined as: leukopenia (WBC \< 3×10⁹/L), anemia (Hb \< 90 g/L); coagulopathy, thrombocytopenia (PLT count \< 50×10⁹/L).
• •8. Renal insufficiency with serum creatinine \> 221 μmol/L (or 2.5 mg/dL) and/or end-stage renal disease requiring renal dialysis, as determined by the investigator after comprehensive assessment.
• •9. Severe hepatic insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5× upper limit of normal; serum total bilirubin (STB) \> 2× upper limit of normal.
• •10. Hypersensitivity to contrast media, materials of the Aorta Vascular Plug, or the delivery system.
• •11. Female subjects who are pregnant or breastfeeding.
• •12. Concurrent participation in another clinical trial of drugs or devices.
• •13. Patients with a life expectancy of less than 12 months (e.g., advanced malignant tumor).
• •14. Any other medical conditions or abnormalities that, in the investigator's opinion, render the subject ineligible for this study.
• •After completion of the stent-graft procedure (including implantation of stents for the proximal and/or distal tears as necessary), DSA angiography revealed:
• •1. Presence of other vascular lesions (e.g., coronary, renal, mesenteric arteries, etc.) requiring intervention, resulting in an impact on the postoperative medical regimen.
• •2. Proximal Type I endoleak or Type III endoleak.
• •3. Presence of a tear in the descending aorta above the upper margin of the celiac trunk ostium.