RecruitingAscitesVariceal BleedingPortal Hypertension Related to Cirrhosis
VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: W.L.Gore & Associates
You may qualify if…
- ✓ 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).
You may not qualify if…
- ✕ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07390344 · last updated 2026-10-05