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Active Not Recruiting
NCT05661331
VIATORR Device Registry
Conditions: Chronic Liver Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 196
Sponsor: W.L.Gore & Associates
Location: Medical University of Vienna - Department of Internal Medicine III Vienna
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.
Eligibility Criteria
Inclusion Criteria:
1. Patient is eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion for TIPS creation
2. Patient is ≥18 years of age
3. Capable of complying with protocol requirements, including follow-up
4. Signed informed consent by patient
Exclusion Criteria:
1. Unable or not willing to sign informed consent
2. Patient is enrolled in an investigational study
3. Patient has been previously enrolled in this registry
4. Pregnant or breastfeeding female at time of informed consent signature
5. Any other condition which in the judgement of the investigator would preclude adequate registry participation
Source: ClinicalTrials.gov (NCT05661331). StuddyBuddy aggregates publicly available trial information.
