Recruiting

GORE TIPS

Sponsor:

W.L.Gore & Associates

Code:

NCT07390344

Conditions

Ascites

Variceal Bleeding

Portal Hypertension Related to Cirrhosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT07390344

Start date

Jul 20, 2026

Status verified date

Sep, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. The subject has any portal vein thrombosis, including both occlusive and non-occlusive thrombosis.
2. The subject has received a liver transplantation. Patients on the transplant list are still eligible.
3. The subject has a life expectancy of less than 6 months.
4. 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.
5. 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.
6. The subject is enrolled in another investigational study, unless agreed in advance in writing by the Sponsor.
7. The subject is pregnant at the time of informed consent signature.
8. The subject has any other condition which in the judgement of the investigator would preclude adequate Study participation.

Study Design

Enrollment

152 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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

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).

Primary outcome measure

  • Proportion of Subjects achieving primary patency through 2 years [ Time Frame: Shunt primary patency will be analyzed at 1, 3, 6, 12 and 24 months. ]

Central Contacts and Locations

Central contacts

The VIATIPS clinical study team

800-437-8181viatips@wlgore.com

Locations

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Principal Investigator:

Bryan Nicholas Swilley, MD

More Information

Sponsor

W.L.Gore & Associates

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by W.L.Gore & Associates on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.