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

Korábbi kezelés

• The subject has received a liver transplantation. Patients on the transplant list are still eligible.

Más betegség

• The subject has any portal vein thrombosis, including both occlusive and non-occlusive thrombosis.
• 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 has any other condition which in the judgement of the investigator would preclude adequate Study participation.

Életkor

• 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.

Egyéb

• The subject has a life expectancy of less than 6 months.
• 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 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).