NCT05489588

The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study

Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, non-randomized, multicenter, single-arm, clinical 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 iliofemoral venous obstruction.

Detailed description

A maximum of 30 clinical sites across the U.S. will participate in the study. One hundred and sixty-five 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 33 treated subjects per site. 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

• Venous Thromboses
• Venous Disease
• Venous Leg Ulcer
• Venous Stasis
• Venous Ulcer
• Venous Stenosis
• Venous Occlusion
• Vein Thrombosis
• Vein Occlusion
• Vein Disease

Interventions

Type	Name	Description
DEVICE	GORE® VIAFORT Vascular Stent	Treatment of unilateral symptomatic iliofemoral venous obstruction with the GORE® VIAFORT Vascular Stent.

Timeline

• Start date: 2023-03-02
• Primary completion: 2026-08-01
• Completion: 2031-03-01
• First posted: 2022-08-05
• Last updated: 2026-04-09

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated device study