VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)

NCT07390344 | Not Yet Recruiting FDA Device

• 1 other identifier: VTR 25-07
• Study Type: observational
• Target: 152
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Registry will look at patients being treated with a transjugular intrahepatic portosystemic shunt (TIPS) procedure for portal hypertension. The purpose of this Registry is to collect data on the safety and performance of the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) for 2 years in real world setting. Additionally, data will be collected on the safety and performance of the GORE TIPS Set when utilized.

Conditions

Ascites; Variceal Bleeding; Portal Hypertension Related to Cirrhosis

Keywords

portal hypertension; TIPS; cirrhosis; decompensated; Transjugular Intrahepatic Portosystemic Shunt

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects achieving primary patency through 2 years

  Freedom from shunt occlusion on imaging or from reintervention due to shunt dysfunction (occlusion or thrombosis on imaging or significant stenosis confirmed by venography).

  Shunt primary patency will be analyzed at 1, 3, 6, 12 and 24 months.

Secondary Outcomes (5)

• Proportion of Subject procedures that are a technical success

  Day 0

• Reduction in portosystemic gradient (PSG)

  Day 0

• Proportion of Subjects with variceal rebleeding through 2 years

  Variceal rebleeding will be analyzed at 1, 3, 6, 12 and 24 months.

• Rate of large volume paracentesis (LVP) through 2 years per subject-month

  LVP frequency will be analyzed at 1, 3, 6, 12, and 24 months.

• Change in Quality of Life from baseline

  Baseline and 1, 3, 6, 12, and 24 months

Study Arms (1)

Subjects treated for portal hypertension with the Registry device

The study population consists of patients treated with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 6-10mm for portal hypertension and its complications including but not limited to variceal bleeding and/or ascites.

Device: GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)

Interventions

GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) DEVICE

The GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) was developed and approved for the treatment of portal hypertension and its complications such as bleeding from enlarged or swollen veins (variceal bleeding) and abnormal build-up of fluid in the abdomen that does not respond to therapy (ascites which recurs despite conventional treatment). The Registry Device is a small tube (stent) that creates a pathway for blood flow. It consists of a metal frame (nitinol), covered with a thin, flexible material called expandable polytetrafluoroethylene (ePTFE).

Subjects treated for portal hypertension with the Registry device

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

Subjects treated with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 6-10mm for portal hypertension and its complications including, but not limited to, variceal bleeding and/or ascites.

You may qualify if:

• The subject is eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 6-10mm for de novo TIPS creation.
• The subject has cirrhotic portal hypertension.
• The subject is ≥18 years of age.
• The subject is capable of complying with protocol requirements, including follow up.
• The subject or legal representative signed the informed consent form (ICF).

You may not qualify if:

• The subject has any portal vein thrombosis, including both occlusive and non-occlusive thrombosis.
• The subject has received a liver transplantation. Patients on the transplant list are still eligible.
• The subject has a life expectancy of less than 6 months.
• The subject has extrahepatic or hepatic malignancy or a history of previous malignancy, unless treated curatively ≥5 years prior to enrollment. Subjects with non-melanoma skin cancer and/or carcinoma in situ of the cervix remain eligible.
• The subject has inadequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of \> 25 or Child Pugh Score of \> 14.
• The subject is enrolled in another investigational study, unless agreed in advance in writing by the Sponsor.
• The subject is pregnant at the time of informed consent signature.
• The subject has any other condition which in the judgement of the investigator would preclude adequate Study participation.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

MeSH Terms

Conditions

Ascites; Hypertension, Portal; Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Central Study Contacts

The VIATIPS clinical study team

CONTACT

800-437-8181; viatips@wlgore.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 5, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: February 10, 2026

Record last verified: 2026-02