clinical trial · NCT07538609
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
W.L.Gore & Associates·N/A·not yet recruiting·n = 150
Venous ThrombosesVenous DiseaseVenous Leg UlcerVenous StasisVenous UlcerVenous StenosisVenous OcclusionVein ThrombosisGORE® VIABAHN® FORTEGRA Venous Stent
brief summary
This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.
started
Oct 7, 2026
primary completion
May 1, 2029
completion
May 1, 2031
last updated
Apr 20, 2026
detailed description
A maximum of 35 clinical investigative sites in the U.S. will participate in this study. One hundred and fifty subjects are intended to be implanted with the GORE® VIABAHN® FORTEGRA Venous Stent in this study, with a limit of 30 treated subjects per site. Subjects will be evaluated through hospital discharge and return for follow-up visits at 1, 6, 12, 24, and 36 months post-treatment.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol