NCT07390344Recruiting
VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 152 (estimated)
- First submitted
- 28 Jan 2026
- Start date
- 20 Jul 2026
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- W.L.Gore & Associates
- Diseases
- High blood pressure
- NCT number
- NCT07390344
What you commit to
- Study type: Observational
- Planned participants: 152
- From 20 Jul 2026 to the primary completion date, 30 Sept 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The subject has received a liver transplantation. Patients on the transplant list are still eligible.
Other illness
- 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.
Age
- 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.
Other
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.