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The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study

NCT05489588 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

GORE® VIAFORT Vascular Stent

Treatment of unilateral symptomatic iliofemoral venous obstruction with the GORE® VIAFORT Vascular Stent.

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Kush Desai, MD · Northwestern University

  • Kathleen Gibson, MD · Lake Washington Vascular Surgeons

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-02
Primary Completion
2026-08-31
Completion
2031-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05489588 on ClinicalTrials.gov