To validate the safety and efficacy of TIPS (Transjugular Intrahepatic Portosystemic Shunt) using PTFE covered stent in the treatment of portal hypertension.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
177
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.
Fujian Provincial Hospital
Fuzhou, Fujian, China
RECRUITINGThe first affiliated hospital of Guangzhou Medical University
Guangzhou, Guangzhou, China
RECRUITINGShanghai Public Health Clinical Center
Shanghai, Jinshan, China
RECRUITINGPrimary 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.
Time frame: 1 year
Technical success rate
Successful implantation of a PTFE covered stent to create an intrahepatic portosystemic shunt and successful retrieval of the delivery system.
Time frame: immediately after procedure
Procedure success rate
PPG (portosystemic pressure gradient) reduces more than 20% or PPG \<=12mmHg
Time frame: immediately after procedure
Treatment success rate
Treatment success is defined as the success of the procedure without major adverse event.
Time frame: during the perioperative period
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First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
RECRUITING