Clinical Study of PTFE Covered Stent for Treating Portal Hypertension

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

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

Study Overview

• Status: Recruiting
• Conditions: Portal Hypertension
• Intervention / Treatment: Device: Transjugular Intrahepatic Portosystemic shunt

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..

• Study Type: Interventional
• Enrollment (Estimated): 177
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Echo Hu; Phone Number: 08615221991087; Email: echo_hu@enlight-medical.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Provincial Hospital
      • Contact: Zhuting Fang, MD
  • Guangzhou
    • Guangzhou, Guangzhou, China
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Bin Xiong, MD
  • Jinshan
    • Shanghai, Jinshan, China
      • Recruiting
      • Shanghai Public Health Clinical Center
      • Contact: Min Yuan, MD
  • Shanxi
    • Taiyuan, Shanxi, China
      • Recruiting
      • First Hospital of Shanxi Medical University
      • Contact: Duiping Feng, MD
      • Principal Investigator: Duiping Feng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PTFE covered stent; Use the experimental device, PTFE covered stent to treat protal hypertension.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Procedure success rate	PPG (portosystemic pressure gradient) reduces more than 20% or PPG <=12mmHg	immediately after procedure
Treatment success rate	Treatment success is defined as the success of the procedure without major adverse event.	during the perioperative period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary patency rate	Second patency was defined as graft stenosis or occlusion with patency restored and maintained by TIPS revision.	1 year
all cause mortalidy		through study completion, an average of 1 year
Device-related adverse events		through study completion, an average of 1 year
Serious adver events		through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Enlight Medical Technologies (Shanghai) Co., Ltd
• Investigators: Principal Investigator: Bin Xiong, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: transjugular intrahepatic portosystemic shunt
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Liver Diseases; Hypertension; Hypertension, Portal
• Other Study ID Numbers: YM-2023-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No