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VIATORR Device Registry
Sponsor: W.L.Gore & Associates
Summary
The primary objective is to confirm the clinical performance and safety of the GORE® VIATORR® TIPS (Transjugular Intrahepatic Portosystemic Shunt) Endoprosthesis with Controlled Expansion throughout the device functional lifetime of 3 years in real world setting. The secondary objective is to collect information on quality of life after treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion. Additionally, data will be collected on the safety and performance of the GORE TIPS Set when utilized.
Official title: VIATORR Device Registry - Post-Market Clinical Follow-Up (PMCF) Registry of the GORE® VIATORR® TIPS Endoprosthesis With Controlled Expansion to Treat Portal Hypertension and Its Complications
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
196
Start Date
2023-02-21
Completion Date
2028-12-31
Last Updated
2025-08-26
Healthy Volunteers
No
Conditions
Interventions
Transjugular intrahepatic portosystemic shunt
The GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion is indicated for use in the treatment of portal hypertension and its complications such as variceal bleeding and refractory ascites. The GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion is a current generation of the GORE® VIATORR® TIPS Endoprosthesis. The GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion was designed to build on the success of the GORE® VIATORR® TIPS Endoprosthesis. The GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion allows for intraoperative diameter control to reach a targeted portal pressure gradient.
Locations (7)
Medical University of Vienna - Department of Internal Medicine III
Vienna, Austria
Hôpital La Pitiè-Salpétrière
Paris, France
University Medical Center Freiburg, Department of Medicine II
Freiburg im Breisgau, Germany
Westfälische Wilhelms-Universität Münster
Münster, Germany
AOU Careggi
Florence, Italy
University Hospital Modena
Modena, Italy
Hospital Clinic Barcelona
Barcelona, Spain