Early TIPS for Ascites Study

Study Overview
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Brief Summary
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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.

Official Title
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The GORE® VIATORR® TIPS Endoprosthesis Versus Large-Volume Paracentesis for the Treatment of Ascites in Patients With Portal Hypertension

Conditions
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Liver Cirrhosis, Portal Hypertension, Ascites

Intervention / Treatment
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* Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
* Procedure: LVP
* Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIPS<br>TIPS with GORE® VIATORR® TIPS Endoprosthesis | Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis<br>* TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis<br>|
| Active Comparator: LVP<br>Large Volume Paracentesis *A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure). | Procedure: LVP<br>* Large Volume Paracentesis<br>Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplant-free Survival | Time from randomization to death from any cause prior to transplant. Subjects who undergo liver transplant will be censored at the time of transplant. Subjects without an event will be censored at the date of last follow-up. Note: The outcome entered below is the number of participants who were either alive or had a liver transplant at time of study termination. | Through 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Time from randomization to death from any cause. Subjects without an event will be censored at the date of last follow-up. > *Note: Outcome measure entered below is number of subjects alive at time of study termination. | Through 24 months | 
| Time to Transplant | Time from randomization to transplant. Subjects without an event will be censored at the date of last follow-up or date of death without transplant. *Note: Outcome measure entered is number of subjects who received a liver transplant at time of study termination. | Through 24 months | 
| Frequency of Paracentesis | Number of paracentesis post randomization | Through 24 months | 
| Frequency of Hepatic Encephalopathy | Number of episodes of West Haven grade 2 or greater | Through 24 months | 
| Procedural Success | Successful creation of a VIATORR(R) device lined portosystemic shunt spanning a hepatic vein and intrahepatic branch of the portal vein *Note: Control (LVP) arm includes only subjects who crossed over to TIPS | Time of TIPS Procedure (within 2 weeks of enrollment for TIPS arm, at least 6 months after enrollment for Control arm crossover participants) | 
| Liver Disease Complications (Adverse Events) | Overall frequency and component frequencies. Complications will include hepatic encephalopathy, hepatic hydrothorax, hepatoma, hepatorenal syndrome (Type 1 or Type 2), hyponatremia (<130mEq / L), spontaneous bacterial peritonitis, and variceal bleeding. | Through 24 months |