Clinical Study of PTFE Covered Stent for Treating Portal Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2026-06-30

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.

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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..

Conditions

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Portal Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PTFE covered stent

Use the experimental device, PTFE covered stent to treat protal hypertension.

Group Type EXPERIMENTAL

Transjugular Intrahepatic Portosystemic shunt

Intervention Type DEVICE

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.

Interventions

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Transjugular Intrahepatic Portosystemic shunt

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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No