Portal Hypertension
Conditions
Keywords
transjugular intrahepatic portosystemic shunt
Brief 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..
Interventions
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.
Sponsors
Enlight Medical Technologies (Shanghai) Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary shunt patency rate | 1 year | shunt dysfunction was defined as a TIPS stenosis \>=50% or complete occlusion. Primary patency referred to continuous unassisted patency of the shunt. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment success rate | during the perioperative period | Treatment success is defined as the success of the procedure without major adverse event. |
| Technical success rate | immediately after procedure | Successful implantation of a PTFE covered stent to create an intrahepatic portosystemic shunt and successful retrieval of the delivery system. |
| Procedure success rate | immediately after procedure | PPG (portosystemic pressure gradient) reduces more than 20% or PPG \<=12mmHg |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serious adver events | through study completion, an average of 1 year | — |
| Secondary patency rate | 1 year | Second patency was defined as graft stenosis or occlusion with patency restored and maintained by TIPS revision. |
| all cause mortalidy | through study completion, an average of 1 year | — |
| Device-related adverse events | through study completion, an average of 1 year | — |
Countries
China
Contacts
Primary ContactEcho Hu
Outcome results
None listed