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

Plain Language Summary

Simplified for easier understanding

This study tests a PTFE-covered stent used in a procedure called TIPS (transjugular intrahepatic portosystemic shunt) for treating portal hypertension — dangerously high pressure in the blood vessels of the liver, usually caused by cirrhosis. The PTFE covering may help keep the stent open longer and reduce complications. **You may be eligible if:** - You are between 18 and 85 years old - You have cirrhosis-related portal hypertension that requires a TIPS procedure - You are willing and able to follow the study protocol **You may NOT be eligible if:** - You have chronic heart or lung disease - You have an active or suspected serious infection in the liver or bile ducts - You have other conditions the doctors feel make you unsuitable for the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.