A Prospective, Multicenter, Single-arm Clinical Study of PTFE Covered Stent for Treating Portal Hypertension.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Portal Hypertension
- Sponsor
- Enlight Medical Technologies (Shanghai) Co., Ltd
- Enrollment
- 177
- Locations
- 4
- Primary Endpoint
- Primary shunt patency rate
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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 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..
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Primary shunt patency rate
Time Frame: 1 year
shunt dysfunction was defined as a TIPS stenosis \>=50% or complete occlusion. Primary patency referred to continuous unassisted patency of the shunt.
Secondary Outcomes
- Technical success rate(immediately after procedure)
- Procedure success rate(immediately after procedure)
- Treatment success rate(during the perioperative period)