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.
Plain-language title generated from the registry record
Registry title: VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
Key facts
- Where
- Florence, ItalySee the site
AI summary: who the study is looking for
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
Read by machine on 12 November 2026.
Where in Italy
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyContact: Francesco VizzuttiTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- W.L.Gore & Associates
- Trial code
- NCT07390344
- Record updated
- 9 November 2026
- Original description
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
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.
Inclusion: 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).
Exclusion: 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.