Clinical Study of PTFE Covered Stent for Treating Portal Hypertension

Portal Hypertension Clinical Trial

Official title:

A Prospective, Multicenter, Single-arm Clinical Study of PTFE Covered Stent for Treating Portal Hypertension.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117735
• Other study ID #: YM-2023-002
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Enlight Medical Technologies (Shanghai) Co., Ltd
• Contact: Echo Hu
• Phone: 08615221991087
• Email: echo_hu[@]enlight-medical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 177
• Est. completion date: June 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal
• Portal Hypertension

Intervention

Device:
• Transjugular 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.

Locations

Country	Name	City	State
China	Fujian Provincial Hospital	Fuzhou	Fujian
China	The first affiliated hospital of Guangzhou Medical University	Guangzhou	Guangzhou
China	Shanghai Public Health Clinical Center	Shanghai	Jinshan
China	First Hospital of Shanxi Medical University	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Enlight Medical Technologies (Shanghai) Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Secondary patency rate	Second patency was defined as graft stenosis or occlusion with patency restored and maintained by TIPS revision.	1 year
Other	all cause mortalidy		through study completion, an average of 1 year
Other	Device-related adverse events		through study completion, an average of 1 year
Other	Serious adver events		through study completion, an average of 1 year
Primary	Primary shunt patency rate	shunt dysfunction was defined as a TIPS stenosis >=50% or complete occlusion. Primary patency referred to continuous unassisted patency of the shunt.	1 year
Secondary	Technical success rate	Successful implantation of a PTFE covered stent to create an intrahepatic portosystemic shunt and successful retrieval of the delivery system.	immediately after procedure
Secondary	Procedure success rate	PPG (portosystemic pressure gradient) reduces more than 20% or PPG <=12mmHg	immediately after procedure
Secondary	Treatment success rate	Treatment success is defined as the success of the procedure without major adverse event.	during the perioperative period