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To validate the safety and efficacy of TIPS (Transjugular Intrahepatic Portosystemic Shunt) using PTFE covered stent in the treatment of portal hypertension.
Full 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..
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Inclusion criteria
Subjects must meet all of the following criteria to be eligible for this study:
Exclusion criteria
Subjects meeting any of the following criteria are not eligible for this study:
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177 participants in 1 patient group
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Central trial contact
Echo Hu
Data sourced from clinicaltrials.gov
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