Clinical trial NCT06117735: Clinical Study of PTFE Covered Stent for Treating Portal Hypertension
Official title: A Prospective, Multicenter, Single-arm Clinical Study of PTFE Covered Stent for Treating Portal Hypertension.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Portal Hypertension
Keywords: transjugular intrahepatic portosystemic shunt
Lead sponsor: Enlight Medical Technologies (Shanghai) Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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..

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;
* Intending or currently participating in another interventional clinical trial;
* Other conditions deemed inappropriate for participation in this study by the investigator.

Primary outcomes:
measure: Primary shunt patency rate
timeFrame: 1 year
Secondary outcomes:
measure: Technical success rate
timeFrame: immediately after procedure
measure: Procedure success rate
timeFrame: immediately after procedure
measure: Treatment success rate
timeFrame: during the perioperative period
Other outcomes:
measure: Secondary patency rate
timeFrame: 1 year
measure: all cause mortalidy
timeFrame: through study completion, an average of 1 year
measure: Device-related adverse events
timeFrame: through study completion, an average of 1 year
measure: Serious adver events
timeFrame: through study completion, an average of 1 year
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Guangzhou
country: China
facility: The first affiliated hospital of Guangzhou Medical University
state: Guangzhou
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Jinshan
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Bin Xiong
role: PRINCIPAL_INVESTIGATOR
References: