VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorW.L.Gore & Associates
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
The subject has any portal vein thrombosis, including both occlusive and non-occlusive thrombosis.
The subject has received a liver transplantation. Patients on the transplant list are still eligible.
The subject has a life expectancy of less than 6 months.
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.
Trial design
Treatments tested in this trial
- GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)
Treatment groups
152 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov