VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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 population
Subjects treated with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 6-10mm for portal hypertension and its complications including, but not limited to, variceal bleeding and/or ascites.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)
DeviceThe 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). The Registry Device is a small tube (stent) that creates a pathway for blood flow. It consists of a metal frame (nitinol), covered with a thin, flexible material called expandable polytetrafluoroethylene (ePTFE).
Treatment groups
152 Participants
are divided into 1 treatment groupGroup A: Subjects treated for portal hypertension with the Registry device1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Subjects achieving primary patency through 2 years
Freedom from shunt occlusion on imaging or from reintervention due to shunt dysfunction (occlusion or thrombosis on imaging or significant stenosis confirmed by venography).
Time frame
Shunt primary patency will be analyzed at 1, 3, 6, 12 and 24 months.Secondary outcomes
1
Proportion of Subject procedures that are a technical success
Successful delivery and deployment of the device to create an intrahepatic shunt connection between the portal and hepatic circulations.
Time frame
Day 02
Reduction in portosystemic gradient (PSG)
Difference between the pre-TIPS gradient (prior to TIPS device deployment) and the post-TIPS gradient (at completion of procedure).
Time frame
Day 03
Proportion of Subjects with variceal rebleeding through 2 years
Variceal rebleeding is defined as any endoscopically proven variceal bleeding event that occurs post procedure. The inability to control acute bleeding after device implant at time of procedure will count as a rebleeding event on day 0.
Time frame
Variceal rebleeding will be analyzed at 1, 3, 6, 12 and 24 months.4
Rate of large volume paracentesis (LVP) through 2 years per subject-month
Any reported episode of large volume (≥ 5 L) paracentesis following the TIPS procedure.
Time frame
LVP frequency will be analyzed at 1, 3, 6, 12, and 24 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov