Recruiting

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

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.

ClinicalTrials.gov IDNCT07390344

PhaseNot Applicable

Enrollment152

SponsorW.L.Gore & Associates

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Ascites, Variceal Bleeding, Portal Hypertension Related to Cirrhosis

About this study

Interventions

Device: 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 outcomes

Proportion of Subjects achieving primary patency through 2 years (Shunt primary patency will be analyzed at 1, 3, 6, 12 and 24 months.)

Eligibility information

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 locations

Emory University Hospital, Atlanta, Georgia 30322 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.