VIATORRĀ® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
152 participantsStarted 2026-06
Plain-language summary
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 GOREĀ® VIATORRĀ® 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. The subject is eligible for treatment with the GOREĀ® VIATORRĀ® TIPS Endoprosthesis with Controlled Expansion 6-10mm for de novo TIPS creation.
ā. The subject has cirrhotic portal hypertension.
ā. The subject is ā„18 years of age.
ā. The subject is capable of complying with protocol requirements, including follow up.
ā. The subject or legal representative signed the informed consent form (ICF).
Exclusion criteria
ā. The subject has any portal vein thrombosis, including both occlusive and non-occlusive thrombosis.
ā. The subject has received a liver transplantation. Patients on the transplant list are still eligible.
ā. The subject has a life expectancy of less than 6 months.
ā. The subject has extrahepatic or hepatic malignancy or a history of previous malignancy, unless treated curatively ā„5 years prior to enrollment. Subjects with non-melanoma skin cancer and/or carcinoma in situ of the cervix remain eligible.
ā. 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.
ā. The subject is enrolled in another investigational study, unless agreed in advance in writing by the Sponsor.
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What they're measuring
1
Proportion of Subjects achieving primary patency through 2 years
Timeframe: Shunt primary patency will be analyzed at 1, 3, 6, 12 and 24 months.