VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
W.L.Gore & Associates
Study ID
NCT07390344
Status
Recruiting
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Conditions

  • Ascites
  • Portal Hypertension Related to Cirrhosis
  • Variceal Bleeding

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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.

Key Dates

First listed
Feb 5, 2026
Start date
Jul 20, 2026
Status verified
Sep 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
152 participants (estimated)

Arms

  • Arm: 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.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322
Bryan Nicholas Swilley, MD
[email protected]
404-712-7962
Bryan Nicholas Swilley, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Emory University Hospital· Atlanta, GA

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