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

Inclusion Criteria:

1. The subject who is 18 years old or above but 75 years old or below;

2. The subject who is diagnosed with portal hypertension caused by liver cirrhosis withthe history of gastrointestinal variceal bleeding or bleeding, hepatic hydrothorax,and refractory or recurrent ascites;

3. The subject must have adequate functional hepatic reserve with a Model for End-StageLiver Disease (MELD) Score of ≤13 or Child-Pugh Score of ≤18;

4. The subject with platelet count≥ 20×10^9 /L;

5. 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 thefollow-up period according to the requirements of the clinical trial.

Exclusion Criteria:

1. The subject who is pregnant or lactating or plan to get pregnant during the clinicaltrial;

2. According to the judgment of investigator, the subject with main portal veinthrombosis which thrombus occupying >50% of the portal vein lumen and affectingpostoperative hemodynamics;

3. The subject who has received surgical or interventional treatment (such as TIPS,surgical shunt and retrograde transvenous obliteration (-RTO) for treatment ofcomplications from portal hypertension. Note: The subject who have received -RTO forvariceal bleeding at least 8 weeks before signing the informed consent form can beincluded 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 parenchymabetween 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) andobstructive 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 aboveaccording to the West Haven Criteria);

13. The subject with a TBIL level higher than 51.3 μmol/L (excluding the Patients withcholestatic 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 severehepatopulmonary syndrome;

19. The subject with uncontrolled systemic infection or inflammation;

20. The subject with severe renal insufficiency (Scr level:>199.5 μmol/L) or needingto receive dialysis;

21. The subject known to be allergic to the contrast media or to the constituentmaterials of the TIPS covered segment;

22. The subject with the history of epilepsy or mental illness or with cognitiveimpairment;

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 thisStudy by investigators;

25. The subject who is participating in any other unfinished drug or medical deviceclinical trials.