Early TIPS for Ascites Study

W.L. Gore & Associates

Status: Terminated

Conditions: Portal Hypertension; Liver Cirrhosis; Ascites

Treatments: Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis; Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol; Procedure: LVP

Study type: Interventional

Funder types: Industry

Identifiers

NCT01236339

VTR 10-03

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

TIPS

Experimental group

Description:

TIPS with GORE® VIATORR® TIPS Endoprosthesis

Treatment:

Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis

LVP

Active Comparator group

Description:

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).

Treatment:

Procedure: LVP

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