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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device The intraparenchymal portal vein covered stent
  The 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.
• Device TIPS Covered Stent System GORE
  The GORE® VIATORR® Transjugular Intrahepatic Portosystemic Shunt (TIPS) Covered Stent consists of an implantable covered stent and a percutaneous delivery catheter.

Primary outcome measures

• Postoperative Stent Patency Rate [Time frame: 12 months]

Secondary outcome measures (9)

• Immediate Postoperative Technical Success Rate [Time frame: Immediate postoperative]
• Incidence of Secondary Interventions at 1 Month, 6 Months, and 12 Months Postoperatively [Time frame: 1 Month, 6 Months, and 12 Months]
• Incidence of Stent Dysfunction at 1 Month, 6 Months, and 12 Months Postoperatively [Time frame: 1 Month, 6 Months, and 12 Months]
• Incidence of Major Adverse Events (MAE) at 1 Month, 6 Months, and 12 Months Postoperatively [Time frame: 1 Month, 6 Months, and 12 Months]
• All-Cause Mortality Rates at 1 Month, 6 Months, and 12 Months Postoperatively [Time frame: 1 Month, 6 Months, and 12 Months]
• Incidence of Grade II or Higher Hepatic Encephalopathy at 1 Month, 6 Months, and 12 Months Postoperatively [Time frame: 1 Month, 6 Months, and 12 Months]
• Incidence of Portal Hypertension Rebleeding Confirmed by Endoscopy or Clinical Investigator at 1 Month, 6 Months, and 12 Months Postoperatively (For Original Bleeding Subjects Only) [Time frame: 1 Month, 6 Months, and 12 Months]
• Incidence of Ultrasound-Confirmed Recurrence of Grade 2 or Higher Ascites due to Portal Hypertension at 1 Month, 6 Months, and 12 Months Postoperatively (For Subjects with Original Ascites Only) [Time frame: 1 Month, 6 Months, and 12 Months]
• Incidence of Adverse Events/Serious Adverse Events [Time frame: 12 Months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Southern Medical University Nanfang Hospital — Guangzhou

Identifiers

NCT: NCT06320912 · TIPS01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗