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

Study Overview

• Status: Not yet recruiting
• Conditions: Ascites; Variceal Bleeding; Portal Hypertension Related to Cirrhosis
• Intervention / Treatment: Device: GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)

Detailed Description

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).

Subjects will receive the Registry Device as part of standard treatment for their condition. This means within this Registry, the information collected reflects the use of the Registry Device in typical, everyday medical practice by physicians, often referred to as "real world" data.

Patient total sample size will target a total approximately 152 patients treated with GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm).

Subjects who meet all criteria may be enrolled in the Registry.

The first visit after the procedure will be performed at the day of discharge or within 7 days after the procedure, whatever comes first. Subjects will have follow-up visits at 1 month, 3 months, 6 months, 12 months, and 24 months after their procedure so their health and the performance of the Registry Device can be monitored.

During follow-up visits, the doctor will perform a physical exam, review medications, and perform a condition status assessment. Imaging will not be collected as part of the Registry but may be ordered by the doctor for safety follow-up purposes as imaging is often collected as part of standard medical care.

Subjects will be asked to complete Quality of Life questionnaires at each follow-up visit to collect information on their well-being and daily life.

• Study Type: Observational
• Enrollment (Estimated): 152

Contacts and Locations

• Study Contact: Name: The VIATIPS clinical study team; Phone Number: 800-437-8181; Email: viatips@wlgore.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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); 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in portosystemic gradient (PSG)	Difference between the pre-TIPS gradient (prior to TIPS device deployment) and the post-TIPS gradient (at completion of procedure).	Day 0
Proportion of Subject procedures that are a technical success	Successful delivery and deployment of the device to create an intrahepatic shunt connection between the portal and hepatic circulations.	Day 0
Proportion of Subjects with variceal rebleeding through 2 years	Variceal rebleeding is defined as any endoscopically proven variceal bleeding event that occurs post procedure. The inability to control acute bleeding after device implant at time of procedure will count as a rebleeding event on day 0.	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	Any reported episode of large volume (≥ 5 L) paracentesis following the TIPS procedure.	LVP frequency will be analyzed at 1, 3, 6, 12, and 24 months.
Change in Quality of Life from baseline	Change in Quality of Life as measured by the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) and Chronic Liver Disease Questionnaire (CLDQ).	Baseline and 1, 3, 6, 12, and 24 months

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: portal hypertension; cirrhosis; TIPS; Transjugular Intrahepatic Portosystemic Shunt; decompensated
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Pathological Conditions, Signs and Symptoms; Fibrosis; Hypertension, Portal; Ascites
• Other Study ID Numbers: VTR 25-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes