Status:
RECRUITING
Clinical Study of PTFE Covered Stent for Treating Portal Hypertension
Lead Sponsor:
Enlight Medical Technologies (Shanghai) Co., Ltd
Conditions:
Portal Hypertension
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
To validate the safety and efficacy of TIPS (Transjugular Intrahepatic Portosystemic Shunt) using PTFE covered stent in the treatment of portal hypertension.
Detailed 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 incl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT06117735
Start Date
November 30 2023
End Date
June 30 2026
Last Update
March 12 2024
Active Locations (4)
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1
Fujian Provincial Hospital
Fuzhou, Fujian, China
2
The first affiliated hospital of Guangzhou Medical University
Guangzhou, Guangzhou, China
3
Shanghai Public Health Clinical Center
Shanghai, Jinshan, China
4
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China