Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents in Treating Portal Hypertension and Its Complications

A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Study Evaluating the Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents for the Treatment of Portal Hypertension and Its Complications

The objective of this study is to assess the non-inferiority of the intraparenchymal portal vein covered stent in terms of safety and efficacy for managing portal hypertension and its related complications, in comparison to the currently available TIPS Covered Stent System by GORE.

This study is a prospective, multicenter, randomized controlled, non-inferiority clinical trial. It plans to enroll approximately 258 qualified participants from about 25 research centers nationwide. Participants will be randomly assigned in a 1:1 ratio to either the experimental group or the control group for the treatment of portal hypertension and its related complications. The primary endpoint of the study is the patency rate of the stents 12 months after the initial surgery. All participants will undergo clinical follow-ups at 1 month, 6 months, and 1 year post-stent implantation.

Inclusion Criteria:

• Age 18-75 years (inclusive); male or non-pregnant female.
• Diagnosed with cirrhosis and associated complications of portal hypertension (such as esophageal and gastric variceal bleeding, refractory ascites), and meeting the consensus recommendations for TIPS indications (see Appendix 5).
• Participants must understand the purpose of the trial, voluntarily participate, sign an informed consent form, and be willing to complete the follow-up according to the project requirements.

Exclusion Criteria:

• Severe right heart failure, congestive heart failure (LVEF < 40%), or severe valvular heart dysfunction.
• Uncontrolled systemic infection or inflammation.
• Persistent moderate to severe pulmonary hypertension after treatment (tricuspid regurgitant peak velocity > 3.4 m/s or pulmonary artery systolic pressure > 50 mmHg).
• Patients in hepatic encephalopathy coma or comatose phase (West Haven Criteria Stage III, IV).
• Severe liver dysfunction, Child-Pugh score > 13, or MELD score > 18.
• Serum creatinine (Scr) > 178 umol/L or on dialysis.
• Stage IIIa or higher liver malignancy.
• Budd-Chiari syndrome, hepatic veno-occlusive disease, or obstructive cholestasis.
• Polycystic liver disease.
• Unrectifiable coagulopathy (INR > 5 or PLT count < 20 x 10^9/L).
• Main portal vein thrombosis occupying > 50% of the lumen area or cavernous transformation of the portal vein.
• Previous TIPS procedure or planned liver transplantation within a year.
• Allergy to contrast agents or nickel-titanium alloys.
• Life expectancy less than 1 year.
• Participation in other drug or medical device clinical trials within three months before screening.
• Other conditions deemed by the researcher as unsuitable for participation in this clinical trial.