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Clinical Trials/NCT01236339
NCT01236339TerminatedNot Applicable

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

W.L.Gore & Associates2 sites in 1 country26 target enrollmentStarted: December 1, 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
26
Locations
2
Primary Endpoint
Transplant-free Survival
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 69 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Transplant-free Survival

Time Frame: Through 24 months

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.

Secondary Outcomes

  • Overall Survival(Through 24 months)
  • Time to Transplant(Through 24 months)
  • Frequency of Paracentesis(Through 24 months)
  • Frequency of Hepatic Encephalopathy(Through 24 months)
  • Procedural Success(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)(Through 24 months)

Investigators

Sponsor
W.L.Gore & Associates
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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