Clinical Study of PTFE Covered Stent for Treating Portal Hypertension

Study Overview
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Brief Summary
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To validate the safety and efficacy of TIPS (Transjugular Intrahepatic Portosystemic Shunt) using PTFE covered stent in the treatment of portal hypertension.

Detailed Description
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This trial is a prospective multi-center single-arm confirmatory study. A total 177 subjects will be enrolled in multiple centers nationwide. Subjects who meet the trial requirements, fulfill the inclusion criteria, voluntarily participate in the study, and provide informed consent will undergo TIPS using the PTFE covered stent for the treatment of portal hypertension. Follow-up assessments will be conducted at discharge, as well as at 30 days, 90 days, 180 days and 360 days postoperatively. Secondary endpoint measures include surgical success rate, all-cause mortality, device/procedure-related mortality, incidence of adverce events, and serious adverse event rates. The trial aims to comprehensively assess the safety and efficacy of the PTFE covered stent produced by Enlight Medical Technologies (Shanghai) Co., Ltd..

Official Title
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A Prospective, Multicenter, Single-arm Clinical Study of PTFE Covered Stent for Treating Portal Hypertension.

Conditions
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Portal Hypertension

Intervention / Treatment
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* Device: Transjugular Intrahepatic Portosystemic shunt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for this study: Age 18-85 years; Cirrhotic portal hypertension required for TIPS; Willingness to comply with the protocol requirements and ata collection procedures, ability to understand the purpose of the trial, voluntary participation, and signing of informed consent by the subject or legal guardian. Exclusion Criteria: Subjects meeting any of the following criteria are not eligible for this study: Concomitant chronic heart or lung disease; Presence or suspicion of active systemic, hepatobiliary or ascitic fluid infection; Severe hepatic failure (with bilirubin levels of >51.3μmol/L or Child-Pugh >13 or MELD >18); Hepatic encephalopathy; Coagulation disorders; Portal vein thrombosis; Allergies to device components; Extrahepatic malignancy; Pregnant or brestfeeding women or those planning pregnancy during the trial peroid; Intending or currently participating in another interventional clinical trial; Other conditions deemed inappropriate for participation in this study by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTFE covered stent<br>Use the experimental device, PTFE covered stent to treat protal hypertension. | Device: Transjugular Intrahepatic Portosystemic shunt<br>* The experimental device is a class III implanted shunt device, which will be used to create a shunt between intrahepatic and portosystemic to reduce portal hypertension.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary shunt patency rate | shunt dysfunction was defined as a TIPS stenosis >=50% or complete occlusion. Primary patency referred to continuous unassisted patency of the shunt. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | Successful implantation of a PTFE covered stent to create an intrahepatic portosystemic shunt and successful retrieval of the delivery system. | immediately after procedure | 
| Procedure success rate | PPG (portosystemic pressure gradient) reduces more than 20% or PPG <=12mmHg | immediately after procedure | 
| Treatment success rate | Treatment success is defined as the success of the procedure without major adverse event. | during the perioperative period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transjugular intrahepatic portosystemic shunt