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.
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.
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).
Parallel
The intraparenchymal portal vein covered stent
DeviceThe intraparenchymal portal vein covered stent, produced by Shanghai Shenqi Medical Technology Co., Ltd., is used for a transjugular approach. It establishes an artificial shunt between the hepatic vein and the main branches of the portal vein within the liver. This helps in reducing portal venous pressure and alleviating or improving the symptoms of portal hypertension and its complications, such as variceal bleeding, gastropathy, refractory ascites, and/or hepatic hydrothorax.
TIPS Covered Stent System GORE
DeviceThe GORE® VIATORR® Transjugular Intrahepatic Portosystemic Shunt (TIPS) Covered Stent consists of an implantable covered stent and a percutaneous delivery catheter.
Postoperative Stent Patency Rate
In the absence of a secondary intervention, portal venography indicates a luminal narrowing of ≤50% and a portal pressure gradient (PPG) of ≤12mmHg or a reduction of ≥50% from the baseline value prior to the surgery.
Immediate Postoperative Technical Success Rate
Successful insertion and smooth withdrawal of the covered stent and delivery system, successful establishment of a shunt, accurate positioning of the stent, and postoperative angiography showing ≤30% diameter narrowing.
Incidence of Secondary Interventions at 1 Month, 6 Months, and 12 Months Postoperatively
Incidence of Stent Dysfunction at 1 Month, 6 Months, and 12 Months Postoperatively
Incidence of Major Adverse Events (MAE) at 1 Month, 6 Months, and 12 Months Postoperatively
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