VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)

Starting soon

Conditions studied: Ascites, Variceal Bleeding, Portal Hypertension Related to Cirrhosis

In brief

This Registry will look at patients being treated with a transjugular intrahepatic portosystemic shunt (TIPS) procedure for portal hypertension. The purpose of this Registry is to collect data on the safety and performance of the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) for 2 years in real world setting. Additionally, data will be collected on the safety and performance of the GORE TIPS Set when utilized.

Key facts

Study ID

NCT07390344

Run by

W.L.Gore & Associates

People needed

152

Starts

2026-06-01

Expected to finish

2029-09-30

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 6-10mm for de novo TIPS creation.
• The subject has cirrhotic portal hypertension.
• The subject is ≥18 years of age.
• The subject is capable of complying with protocol requirements, including follow up.
• The subject or legal representative signed the informed consent form (ICF).

You may not qualify if…

• The subject has any portal vein thrombosis, including both occlusive and non-occlusive thrombosis.
• The subject has received a liver transplantation. Patients on the transplant list are still eligible.
• The subject has a life expectancy of less than 6 months.
• The subject has extrahepatic or hepatic malignancy or a history of previous malignancy, unless treated curatively ≥5 years prior to enrollment. Subjects with non-melanoma skin cancer and/or carcinoma in situ of the cervix remain eligible.
• The subject has inadequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of > 25 or Child Pugh Score of > 14.
• The subject is enrolled in another investigational study, unless agreed in advance in writing by the Sponsor.
• The subject is pregnant at the time of informed consent signature.
• The subject has any other condition which in the judgement of the investigator would preclude adequate Study participation.

Full record on ClinicalTrials.gov

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