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The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study

NCT05409976 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2026-04-29

Study results available
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Summary

This study is a prospective, multicenter, non-randomized, single-arm 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 inferior vena cava obstruction with or without combined iliofemoral obstruction in adult patients.

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 symptomatic IVC obstruction with or without combined iliofemoral obstruction with the GORE® VIAFORT Vascular Stent.

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Kush Desai, MD · Northwestern University

  • Stephen Black, MD, FRCS (Ed), FEBVS · Guy's and St Thomas' NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-25
Primary Completion
2026-05-09
Completion
2030-05-09
FDA Device
Yes

Countries

  • United States
  • Australia
  • Germany
  • Ireland
  • Italy
  • New Zealand
  • United Kingdom

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 NCT05409976 on ClinicalTrials.gov