AscitesVIATIPSNCT07390344
VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
An observational study of Ascites and Variceal Bleeding, run by W.L.Gore & Associates at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascites, Variceal Bleeding, Portal Hypertension Related to Cirrhosis
- Type of treatment
- Medical device
- How many people
- 152 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Jul 2026to 30 Sep 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 join
- The subject has any portal vein thrombosis, including both occlusive and non-occlusive thrombosis.
- The subject has received a liver transplantation. Patients on the transplant list are still eligible.
- The subject has a life expectancy of less than 6 months.
- 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 inadequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of > 25 or Child Pugh Score of > 14.
- 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.
- The subject has any other condition which in the judgement of the investigator would preclude adequate Study participation.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Bryan Nicholas Swilley, MD, 404-712-7962, bryan.nicholas.swilley@emory.edu
Bryan Nicholas Swilley, MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Sameer Gadani, MD, 216-444-6640, GADANIS@ccf.org
Sameer Gadani, MD
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Reza Talaie, MD, rtalaie@umn.edu
Reza Talaie, MD
About this study
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.
Read the 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.
- Being tested
- GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)
- Keywords
- portal hypertension, TIPS, cirrhosis, decompensated, Transjugular Intrahepatic Portosystemic Shunt
- Medical subject headings
- Ascites, Hypertension, Portal, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)Device
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Shunt primary patency will be analyzed at 1, 3, 6, 12 and 24 months.
Secondary outcomes (5)
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.
Measured: Day 0
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline and 1, 3, 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start20 Jul 2026
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AscitesStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 152 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390344
- Sponsor's protocol ID
- VTR 25-07
- Acronym
- VIATIPS
- Status last verified
- Oct 2026
- First submitted
- 28 Jan 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes