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Clinical Trial Summary

The objective of this study is to assess the non-inferiority of the intraparenchymal portal vein covered stent in terms of safety and efficacy for managing portal hypertension and its related complications, in comparison to the currently available TIPS Covered Stent System by GORE.


Clinical Trial Description

This study is a prospective, multicenter, randomized controlled, non-inferiority clinical trial. It plans to enroll approximately 258 qualified participants from about 25 research centers nationwide. Participants will be randomly assigned in a 1:1 ratio to either the experimental group or the control group for the treatment of portal hypertension and its related complications. The primary endpoint of the study is the patency rate of the stents 12 months after the initial surgery. All participants will undergo clinical follow-ups at 1 month, 6 months, and 1 year post-stent implantation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06320912
Study type Interventional
Source Shanghai Shenqi Medical Technology Co., Ltd
Contact chaojun gu
Phone +86-13636491192
Email chaojun.gu@sqmedical.com
Status Not yet recruiting
Phase N/A
Start date April 5, 2024
Completion date November 1, 2026

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