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

NCT07538609 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

GORE® VIABAHN® FORTEGRA Venous Stent

Treatment with the GORE® VIABAHN® FORTEGRA Venous Stent.

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Erin Murphy, MD · Atrium Health Sanger Heart and Vascular Institute

  • Parag Patel, MD · Medical College of Wisconsin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-07
Primary Completion
2029-05-31
Completion
2031-05-31
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07538609 on ClinicalTrials.gov