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Tracks safety of a TIPS liver shunt device in people with cirrhosis

Follows adults with cirrhosis and portal hypertension treated with a TIPS shunt device.

Key facts

Who runs it
W.L.Gore & Associates
Where
Atlanta, Cleveland, Dallas, and Minneapolis, United StatesSee the 4 sitesAlso in 1 other country, 1 site
Trial code
Registry title
VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
Status
Recruiting
People taking part
152 people, planned
Started
20 Jul 2026
Expected to end
30 Sept 2029
Type of study
Observational
Treatments tested
  • GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)
Record updated
9 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with portal hypertension caused by cirrhosis who are getting a new TIPS shunt using the GORE VIATORR TIPS Endoprosthesis with Controlled Expansion 6-10mm.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Portal hypertension caused by cirrhosis. Liver function must not be too poor: MELD score no higher than 25 and Child Pugh score no higher than 14.
Earlier treatment
The person must be able to have a first-time (de novo) TIPS made with the GORE VIATORR device. People who have had a liver transplant cannot join; people on the transplant list can.

Main reasons for not taking part

  • Any blood clot in the portal vein
  • Liver transplant already done
  • Life expectancy of less than 6 months
  • Liver cancer or other cancer, now or in the past, unless treated 5 or more years before joining (some skin and cervical cancers are allowed)
  • Pregnant at the time of signing consent

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • The subject has received a liver transplantation. Patients on the transplant list are still eligible
  • The subject has any portal vein thrombosis, including both occlusive and non-occlusive thrombosis
  • 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 has any other condition which in the judgement of the investigator would preclude adequate Study participation
  • 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 a life expectancy of less than 6 months
  • 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

Where in United States

Also in 1 other country, 1 site

  • Emory University HospitalAtlanta, United StatesContact: Bryan Nicholas Swilley, MDTaking people
  • Cleveland ClinicCleveland, United StatesContact: Sameer Gadani, MDTaking people
  • University of Texas Southwestern Medical CenterDallas, United StatesContact: Sanjeeva Kalva, MDTaking people
  • University of MinnesotaMinneapolis, United StatesContact: Reza Talaie, MDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

Additionally, data will be collected on the safety and performance of the GORE TIPS Set when utilized.

The group in the trial

  • 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.

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
Plain-language title
Tracks safety of a TIPS liver shunt device in people with cirrhosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
9 November 2026