Effectiveness and Safety of TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal Hypertension

Exclusion Criteria

• •1. The subject who is pregnant or lactating or plan to get pregnant during the clinical trial;
• •2. According to the judgment of investigator, the subject with main portal vein thrombosis which thrombus occupying \>50% of the portal vein lumen and affecting postoperative hemodynamics;
• •3. The subject who has received surgical or interventional treatment (such as TIPS, surgical shunt and retrograde transvenous obliteration (-RTO) for treatment of complications from portal hypertension. Note: The subject who have received -RTO for variceal bleeding at least 8 weeks before signing the informed consent form can be included in the clinical trial;
• •4. The subject who needs to receive or have received splenectomy;
• •5. The subject who has received or plan to receive liver transplantation;
• •6. The subject who cannot have a shunt channel established in the liver parenchyma between the hepatic vein and the portal vein as determined by the investigators;
• •7. The subject with extrahepatic or hepatic malignancies;
• •8. The subject with Budd-Chiari syndrome and hepatic sinusoidal obstruction syndrome;
• •9. The subject with congenital cystic dilatation of bile duct (Caroli disease) and obstructive dilation of biliary tract;
• •10. The subject with polycystic liver disease;
• •11. The subject with cavernous transformation of the portal vein;
• •12. The subject with severe or refractory hepatic encephalopathy (Grade 2 or above according to the West Haven Criteria);
• •13. The subject with a TBIL level higher than 51.3 μmol/L (excluding the Patients with cholestatic cirrhosis);
• •14. The subject with coagulation disorders (INR: \>2.5);
• •15. The subject with a systolic pressure lower than 80 mmHg;
• •16. The subject with severe tricuspid regurgitation or congestive heart failure;
• •17. The subject with myocardial infarction within the past 3 months;
• •18. The subject with moderate to severe pulmonary arterial hypertension, or severe hepatopulmonary syndrome;
• •19. The subject with uncontrolled systemic infection or inflammation;
• •20. The subject with severe renal insufficiency (Scr level:\>199.5 μmol/L) or needing to receive dialysis;
• •21. The subject known to be allergic to the contrast media or to the constituent materials of the TIPS covered segment;
• •22. The subject with the history of epilepsy or mental illness or with cognitive impairment;
• •23. The subject with the expected survival time of less than 1 year;
• •24. The subject who is otherwise determined as ineligible for participation in this Study by investigators;
• •25. The subject who is participating in any other unfinished drug or medical device clinical trials.