Early TIPS for Ascites Study

• Overall Survival [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]
• Time to Transplant [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]
• Frequency and Volume of Paracentesis [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]
• Frequency of Hepatic Encephalopathy [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]
• Change in MELD Score [ Time Frame: Baseline, Discharge (if applicable), 30 days, 3, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
• Change in Quality of Life [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]
• Procedural Success [ Time Frame: Time of TIPS Procedure ] [ Designated as safety issue: No ]
• Liver Disease Complications (Adverse Events) [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]

• Overall Survival [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]
• Time to Transplant [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]
• Frequency of Large Volume Paracentesis [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]
• Frequency of Hepatic Encephalopathy [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]
• Change in MELD Score [ Time Frame: Baseline, Discharge (if applicable), 30 days, 3, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
• Quality of Life [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]
• Procedural Success [ Time Frame: Time of TIPS Procedure ] [ Designated as safety issue: No ]
• Complications of Portal Hypertension [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]

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.

• Liver Cirrhosis
• Portal Hypertension
• Ascites

• Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
  TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
• Procedure: LVP
  Large Volume Paracentesis

• Experimental: TIPS
  TIPS with GORE® VIATORR® TIPS Endoprosthesis
  Intervention: Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
• Active Comparator: LVP (Large Volume Paracentesis)
  Intervention: Procedure: LVP

Inclusion Criteria:

1. Patient has cirrhosis of the liver with portal hypertension

2. Patient has difficult to treat ascites, defined as at least one of the following:

   • Subject requires paracentesis despite treatment with high dose diuretics [at least 80 mg of furosemide (or 2 mg bumetanide) and 200 mg aldactone (or 20 mg amiloride)] within the last 90 days
   • Subject requires repeated paracentesis (cumulative volume of at least 10 L removed) within a 45 day period
   • Subject requires paracentesis and can not tolerate diuretics due to a documented complication of diuretic therapy
3. Patient has a MELD score ≤18 prior to randomization
4. Patient is 18 years or older and <70 years old at randomization
5. Patient has a creatinine ≤ 2.0 mg/dL
6. Patient has a total bilirubin ≤3.0 mg/dL
7. Patient has a serum sodium ≥ 130 mmol/L
8. Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.
9. Patient, or legal authorized representative, is willing to provide written informed consent prior to enrollment in the study.

Exclusion Criteria:

1. Patient has more than 6 large volume paracenteses of at least 5 liters each within 90 days prior to randomization
2. Patient has a history of spontaneous hepatic encephalopathy requiring hospitalization
3. Patient has hepatic encephalopathy (grade 2 or greater) not responsive to medical management
4. Patient has known hepatocellular carcinoma
5. Patient has complete thrombosis of main portal vein
6. Patient has known pulmonary hypertension (mean PA pressure > 30 mmHg) based on cardiac ultrasound or catheterization
7. Patient has congestive heart failure
8. Patient has active bacterial infection
9. Patient has symptomatic hepatic hydrothorax requiring repetitive thoracenteses
10. Patient has Type 1 hepatorenal syndrome (HRS)
11. Patient has Budd-Chiari syndrome
12. Patient is contraindicated for TIPS placement
13. Patient has had previous TIPS placement