VIATORR Device Registry

NCT05661331 | Active Not Recruiting

• 1 other identifier: VTR 21-09
• Study Type: observational
• Target: 196
• Locations: 5 countries
• Sites: 7

Brief 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.

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

• Shunt primary patency 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.

  Through 3 years

Secondary Outcomes (6)

• Technical success at day 0

  Day 0 - Intervention

• Reduction in PSG at day 0

  Day 0 - Intervention

• Variceal rebleeding through 3 years

  Through 3 years

• Frequency of LVP (Large Volume Paracentesis) through 3 years

  Through 3 years

• Quality of life (EQ-5D-5L) questionnaire compared to baseline at 1, 3, 6, 12, 24, 36 months

  Through 3 years

Study Arms (3)

Ascites

N = Up to 88 treated patients and thereof, approximately 10 subjects with a pre-TIPS LVP frequency ≥ 2 LVP per month

Device: Transjugular intrahepatic portosystemic shunt

Variceal bleeding

N = At least 88 treated patients and thereof, approximately 10 subjects enrolled with Child-Pugh class C

Device: Transjugular intrahepatic portosystemic shunt

Other Primary Indication

Portal vein obstruction or thrombosis, pre-operative TIPS, hepatorenal Syndrome Type 1, hepatorenal Syndrome Type 2, other) N = Approximately 20 treated patients

Device: Transjugular intrahepatic portosystemic shunt

Interventions

Transjugular intrahepatic portosystemic shunt DEVICE

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.

Also known as: TIPS

Ascites; Other Primary Indication; Variceal bleeding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion for portal hypertension and its complications including, but not limited to, variceal bleeding and/or ascites.

You may qualify if:

• Patient is eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion for TIPS creation
• Patient is ≥18 years of age
• Capable of complying with protocol requirements, including follow-up
• Signed informed consent by patient

You may not qualify if:

• Unable or not willing to sign informed consent
• Patient is enrolled in an investigational study
• Patient has been previously enrolled in this registry
• Pregnant or breastfeeding female at time of informed consent signature
• Any other condition which in the judgement of the investigator would preclude adequate registry participation

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (7)

Medical University of Vienna - Department of Internal Medicine III

Vienna, 18-A-1090, Austria

Location

Hôpital La Pitiè-Salpétrière

Paris, 75013, France

Location

University Medical Center Freiburg, Department of Medicine II

Freiburg im Breisgau, 79106, Germany

Location

Westfälische Wilhelms-Universität Münster

Münster, 48149, Germany

Location

AOU Careggi

Florence, 50134, Italy

Location

University Hospital Modena

Modena, 41125, Italy

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Jonel Trebicka, Prof Dr med

  Universitätsklinikum Münster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 22, 2022
• Study Start: February 21, 2023
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); AU (1); DE (2); FR (1); IT (2)