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Clinical Trials in Austria / NCT05661331
Active, not recruiting Observational

VIATORR Device Registry

NCT05661331 · tracked via the Priya Life Science Austria tracker
Sponsor
W.L.Gore & Associates
Phase
Observational
Started
2023-02-21
Last updated
2026-10-07

Condition(s) studied

Chronic Liver Disease

Investigational drug(s) / intervention(s)

Transjugular intrahepatic portosystemic shunt

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Shunt primary patency through 3 years — Through 3 years
    Shunt primary patency is defined as freedom from reintervention due to shunt dysfunction (occlusion or thrombosis on imaging or significant stenosis confirmed by venography) or shunt occlusion. Intentional shunt occlusions of otherwise patent stents will not be considered a loss of primary patency. Shunt primary patency will be analyzed at 1, 3, 6, 12, 24 and 36 months. There is no formal hypothesis that will be tested for the primary endpoint. The analysis of the primary endpoint will be descriptive in nature.

Trial sites (7)

FacilityCityRegionStatus
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

More W.L.Gore & Associates trials in Austria

Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries. Starting soon
Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis Active, not recruiting
Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis Recruiting

Other trials for the same condition

hepatomiR cACLD Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05661331 on ClinicalTrials.gov ↗ ← All trials in Austria