NCT06117735

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: Enlight Medical Technologies (Shanghai) Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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..

Conditions

• Portal Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-30
• Primary completion: 2025-12-30
• Completion: 2026-06-30
• First posted: 2023-11-07
• Last updated: 2024-03-12

Locations

4 sites across 1 country: China