Clinical Study of PTFE Covered Stent for Treating Portal Hypertension

Enlight Medical Technologies

Status: Enrolling

Conditions: Portal Hypertension

Treatments: Device: Transjugular Intrahepatic Portosystemic shunt

Study type: Interventional

Funder types: Industry

Identifiers

NCT06117735

YM-2023-002

Details and patient eligibility

About

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

Full description

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..

Enrollment: 177 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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177 participants in 1 patient group

PTFE covered stent

Experimental group

Description:

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

Treatment:

Device: Transjugular Intrahepatic Portosystemic shunt