Clinical Trial

The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study

Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
critical Enrollment closed, study ongoing 2026-08-13
notable Trial sites reduced: 27 -> 24 locations 2026-08-13
notable Primary completion pushed: 2026-08 -> 2027-08 2026-08-13
Trial Details
NCT Number NCT05489588
Lead Sponsor W.L.Gore & Associates
Conditions Venous Thromboses, Venous Disease, Venous Leg Ulcer, Venous Stasis, Venous Ulcer, Venous Stenosis, Venous Occlusion, Vein Thrombosis +2 more
Enrollment 165 participants
Start Date 2023-03-02
Primary Completion 2027-08 (estimated)
Study Completion 2031-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-12