VIATORR Device Registry

NCT05661331 · tracked via the Priya Life Science Spain tracker

Sponsor

W.L.Gore & Associates

Phase

Observational

Started

2023-02-21

Last updated

2025-08-26

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

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)

Facility	City	Region
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 Spain

Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application Active, not recruiting

Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries Active, not recruiting

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

Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels Active, not 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 Spain