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

Recruitingn/aAges 18 Years - anyAllW.L.Gore & Associates
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. The subject is eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 6-10mm for de novo TIPS creation. 2. The subject has cirrhotic portal hypertension. 3. The subject is ≥18 years of age. 4. The subject is capable of complying with protocol requirements, including follow up. 5. The subject or legal representative signed the informed consent form (ICF). Exclusion Criteria: 1. The subject has any portal vein thrombosis, including both occlusive and non-occlusive thrombosis. 2. The subject has received a liver transplantation. Patients on the transplant list are still eligible. 3. The subject has a life expectancy of less than 6 months. 4. 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. 5. 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. 6. The subject is enrolled in another investigational study, unless agreed in advance in writing by the Sponsor. 7. The subject is pregnant at the time of informed consent signature. 8. The subject has any other condition which in the judgement of the investigator would preclude adequate Study participation.
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What it tests

  • GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)
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Where

3 sites
Emory University Hospital
Atlanta, United States
University of Minnesota
Minneapolis, United States
Cleveland Clinic
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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