Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System

Exclusion Criteria

• •Aortic rupture;
• •Continuous malperfusion of internal artery branches caused by dissection;
• •Had previously received false lumen embolization;
• •Proximal type I endoleak after aortic repair;
• •Abdominal aortic dissection aneurysm diameter \> 5 cm
• •Infectious aortic disease, arteritis, Marfan syndrome (or other connective tissue diseases);
• •Acute systemic infection;
• •History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
• •Cardiac function Grade IV (NYHA rating) or LVEF \< 30%;
• •Hematological abnormalities: leukopenia (WBC \< 3×10\^9/L), anemia (Hb \< 90 g/L); Coagulation dysfunction, thrombocytopenia (PLT count \< 50×10\^9/L);
• •Renal insufficiency: serum creatinine \> 150 umol/L (or 3.0 mg/dL) and/or advanced kidney disease requiring renal dialysis, as determined by the investigator after thorough analysis;
• •Severe liver insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds the normal upper limit by 5 times; Serum total bilirubin (STB) exceeded the normal upper limit by 2 times;
• •Allergic to contrast agents, anesthetics, plugs, and delivery materials;
• •Pregnant, breastfeeding or cannot contraception during the trial period;
• •Participated in clinical trials of other drugs or devices during the same period;
• •Life expectancy is less than 12 months (such as advanced malignant tumors);
• •Investigator judged that not suitable for interventional treatment.