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

Sponsored by W.L.Gore & Associates

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.

The GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) was developed and approved for the treatment of portal hypertension and its complications such as bleeding from enlarged or swollen veins (variceal bleeding) and abnormal build-up of fluid in the abdomen that does not respond to therapy (ascites which recurs despite conventional treatment). Subjects will receive the Registry Device as part of standard treatment for their condition. This means within this Registry, the information collected reflects the use of the Registry Device in typical, everyday medical practice by physicians, often referred to as "real world" data. Patient total sample size will target a total approximately 152 patients treated with GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion …

Where this study is enrolling

Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.