NCT07390344

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 152 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 world setting. Additionally, data will be collected on the safety and performance of the GORE TIPS Set when utilized.

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.

Conditions

• Ascites
• Variceal Bleeding
• Portal Hypertension Related to Cirrhosis

Interventions

Type	Name	Description
DEVICE	GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)	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).

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-09-30
• Completion: 2029-09-30
• First posted: 2026-02-05
• Last updated: 2026-02-10

Regulatory

• FDA-regulated device study