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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
Are there results?
Not yet: the study is under way

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.

The VIATIPS clinical study team contact

800-437-8181

viatips@wlgore.com

United States3 sites, 3 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

    Recruiting

Other trials in United States

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 groups in NCT07390344
Study groupRoleWhat they receive
Subjects treated for portal hypertension with the Registry deviceThe 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.

  1. 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)

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  1. First posted5 Feb 2026
  2. Study start20 Jul 2026
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

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
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

Questions about this trial

What is this clinical trial studying?

An observational study of Ascites and Variceal Bleeding, run by W.L.Gore & Associates at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact The VIATIPS clinical study team (800-437-8181, viatips@wlgore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects achieving primary patency through 2 years (time frame: Shunt primary patency will be analyzed at 1, 3, 6, 12 and 24 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07390344.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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