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Active Not RecruitingNCT05409976

The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study

Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Inferior Vena Cava Obstruction With or Without Combined Iliofemoral Obstruction

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
112 (actual)
Sponsor
W.L.Gore & Associates · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study is a prospective, multicenter, non-randomized, single-arm study to evaluate the performance, safety, and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for treatment of symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction in adult patients.

Detailed description

A maximum of 35 clinical investigative sites across the U.S., Europe, Australia, and New Zealand will participate in this study. One hundred and eleven subjects are intended to be implanted with the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) in this study, with a limit of 22 treated subjects per site and a minimum of 45 patients treated within the United States. Subjects will be evaluated through hospital discharge and return for follow-up visits at 1, 6, 12, 24, 36, 48, and 60 months post-treatment.

Conditions

Interventions

TypeNameDescription
DEVICEGORE® VIAFORT Vascular StentTreatment of symptomatic IVC obstruction with or without combined iliofemoral obstruction with the GORE® VIAFORT Vascular Stent.

Timeline

Start date
2022-10-25
Primary completion
2026-05-01
Completion
2030-05-01
First posted
2022-06-08
Last updated
2025-11-24

Locations

17 sites across 7 countries: United States, Australia, Germany, Ireland, Italy, New Zealand, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT05409976. Inclusion in this directory is not an endorsement.