The GORE® VIATORR® TIPS Endoprosthesis Versus Large-Volume Paracentesis for the Treatment of Ascites in Patients With Portal Hypertension
The GORE® VIATORR® TIPS Endoprosthesis Versus Large-Volume Paracentesis for the Treatment of Ascites in Patients With Portal Hypertension
The purpose of this study is to demonstrate that TIPS with the GORE® VIATORR® TIPS Endoprosthesis improves transplant-free survival compared to LVP alone in patients who have cirrhosis of the liver with portal hypertension and difficult to treat ascites.
Inclusion Criteria:
> Patient has cirrhosis of the liver with portal hypertension
> Patient has difficult to treat ascites
> Patient is 18 years or older and <70 years old at randomization
> Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.
> Patient, or legal authorized representative, is willing to provide written informed consent prior to enrollment in the study.
Exclusion Criteria:
> Patient has more than 6 large volume paracenteses within 90 days prior to randomization
> Patient is contraindicated for TIPS placement
> Patient has had previous TIPS placement