The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study

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

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorW.L.Gore & Associates

About this trial

This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.

Eligibility criteria

Qualifiers

Presence of a lesion necessitating treatment with the GORE® VIABAHN® FORTEGRA Venous Stent, as previously determined by an investigator/sub-investigator.

Patient is at least 18 years of age.

Patient is willing and able to comply with all follow-up evaluations as well as any required medication or compression regimen.

Patient is able to provide informed consent themself.

Disqualifiers

Patient is contraindicated for treatment with the GORE® VIABAHN® FORTEGRA Venous Stent according to the IFU.

Trial design

Treatments tested in this trial

GORE® VIABAHN® FORTEGRA Venous Stent

Treatment groups

150 Participants

are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

W.L.Gore & Associates

Lead sponsor

Source ClinicalTrials.gov