RecruitingNot ApplicableNCT06117735

Clinical Study of PTFE Covered Stent for Treating Portal Hypertension

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

Sponsor

Enlight Medical Technologies (Shanghai) Co., Ltd

Enrollment

177 participants

Start Date

Nov 30, 2023

Study Type

INTERVENTIONAL

Conditions

Portal Hypertension

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria4

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 Criteria12

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.

Interventions

DEVICETransjugular 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.