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

Prior treatment

• 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;
• The subject who needs to receive or have received splenectomy;
• The subject who has received or plan to receive liver transplantation;
• The subject who is participating in any other unfinished drug or medical device clinical trials.

Other illness

• 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;
• The subject with extrahepatic or hepatic malignancies;
• The subject with Budd-Chiari syndrome and hepatic sinusoidal obstruction syndrome;
• The subject with congenital cystic dilatation of bile duct (Caroli disease) and obstructive dilation of biliary tract;
• The subject with polycystic liver disease;
• The subject with severe tricuspid regurgitation or congestive heart failure;
• The subject with myocardial infarction within the past 3 months;
• The subject with moderate to severe pulmonary arterial hypertension, or severe hepatopulmonary syndrome;
• The subject with uncontrolled systemic infection or inflammation;
• The subject with severe renal insufficiency (Scr level:\>199.5 μmol/L) or needing to receive dialysis;
• The subject known to be allergic to the contrast media or to the constituent materials of the TIPS covered segment;
• The subject with the history of epilepsy or mental illness or with cognitive impairment;

Lab values

• The subject with coagulation disorders (INR: \>2.5);

Other

• The subject who is pregnant or lactating or plan to get pregnant during the clinical trial;
• 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;
• The subject with cavernous transformation of the portal vein;
• The subject with severe or refractory hepatic encephalopathy (Grade 2 or above according to the West Haven Criteria);
• The subject with a TBIL level higher than 51.3 μmol/L (excluding the Patients with cholestatic cirrhosis);
• The subject with a systolic pressure lower than 80 mmHg;
• The subject with the expected survival time of less than 1 year;
• The subject who is otherwise determined as ineligible for participation in this Study by investigators;

• The subject who is 18 years old or above but 75 years old or below;
• The subject who is diagnosed with portal hypertension caused by liver cirrhosis with the history of gastrointestinal variceal bleeding or bleeding, hepatic hydrothorax, and refractory or recurrent ascites;
• The subject must have adequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of ≤13 or Child-Pugh Score of ≤18;
• The subject with platelet count≥ 20×10\^9 /L;
• Subjects or their guardians who can understand the content of the clinical trial, voluntarily participate in the clinical trial and sign the ICF and can complete the follow-up period according to the requirements of the clinical trial.