Not Yet Recruiting INTERVENTIONAL NCT07538609

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

Sponsor: W.L.Gore & Associates

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

Interventions GORE® VIABAHN® FORTEGRA Venous Stent

Updated 1 time since 2026 Last updated: Apr 30, 2026 Started: Oct 7, 2026 Primary completion: May 1, 2029 Completion: May 1, 2031

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT07538609, this observational or N/A phase trial focuses on Vein Thrombosis and Venous Disease and remains actively recruiting participants. Sponsored by W.L.Gore & Associates, it has been updated 1 time since 2026, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

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.

Status Flow

Change History

1 version recorded

Not Yet Recruiting [daily]

Eligibility 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.

Contact Information

Sponsor contact:

W.L.Gore & Associates

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.