Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06117735

Clinical Study of PTFE Covered Stent for Treating Portal Hypertension

Led by Enlight Medical Technologies (Shanghai) Co., Ltd · Updated on 2024-03-12

177

Participants Needed

4

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Clinical Study of PTFE Covered Stent for Treating Portal Hypertension

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-85 years
  • Cirrhotic portal hypertension requiring TIPS
  • Willingness to comply with protocol, understand the trial purpose, voluntarily participate, and provide informed consent
Not Eligible

You will not qualify if you...

  • Chronic heart or lung disease
  • Active or suspected systemic, hepatobiliary, or ascitic fluid infection
  • Severe hepatic failure (bilirubin >51.3 µmol/L, Child-Pugh >13, or MELD >18)
  • Hepatic encephalopathy
  • Coagulation disorders
  • Portal vein thrombosis
  • Allergies to device components
  • Extrahepatic malignancy
  • Pregnancy, breastfeeding, or planning pregnancy during the trial
  • Participation in another interventional clinical trial
  • Other conditions deemed inappropriate by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Fujian Provincial Hospital

Fuzhou, Fujian, China

Actively Recruiting

2

The first affiliated hospital of Guangzhou Medical University

Guangzhou, Guangzhou, China

Actively Recruiting

3

Shanghai Public Health Clinical Center

Shanghai, Jinshan, China

Actively Recruiting

4

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Actively Recruiting

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Research Team

E

Echo Hu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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