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.

Study Overview

• Status: Not yet recruiting
• Conditions: Portal Hypertension
• Intervention / Treatment: Device: The intraparenchymal portal vein covered stent; Device: TIPS Covered Stent System 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.

• Study Type: Interventional
• Enrollment (Estimated): 258
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: chaojun gu; Phone Number: +86-13636491192; Email: chaojun.gu@sqmedical.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Southern Medical University Nanfang Hospital
      • Contact: Jianbo Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group(A)	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.
Active Comparator: Group(B)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediate postoperative
Incidence of Secondary Interventions at 1 Month, 6 Months, and 12 Months Postoperatively		1 Month, 6 Months, and 12 Months
Incidence of Stent Dysfunction at 1 Month, 6 Months, and 12 Months Postoperatively		1 Month, 6 Months, and 12 Months
Incidence of Major Adverse Events (MAE) at 1 Month, 6 Months, and 12 Months Postoperatively		1 Month, 6 Months, and 12 Months
All-Cause Mortality Rates at 1 Month, 6 Months, and 12 Months Postoperatively		1 Month, 6 Months, and 12 Months
Incidence of Grade II or Higher Hepatic Encephalopathy at 1 Month, 6 Months, and 12 Months Postoperatively		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)		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)		1 Month, 6 Months, and 12 Months
Incidence of Adverse Events/Serious Adverse Events		12 Months

Collaborators and Investigators

• Sponsor: Shanghai Shenqi Medical Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): April 5, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Portal hypertension
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Liver Diseases; Hypertension; Hypertension, Portal
• Other Study ID Numbers: TIPS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No