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The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study | Clinical Trials | Clareo Health

RECRUITINGNA

The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study

Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction

NCT05489588•W.L.Gore & Associates

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.

Detailed Description

A maximum of 30 clinical sites across the U.S. will participate in the study. One hundred and sixty-five subjects are intended to be implanted with the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) in this study, with a limit of 33 treated subjects per site. Subjects will be evaluated through hospital discharge and return for follow-up visits at 1, 6, 12, 24, 36, 48, and 60 months post-treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•One of the following: Clinical severity class of CEAP 'C' classification ≥3 or rVCSS pain score ≥2.
•Intention to treat the target areas with only the GORE® VIAFORT Vascular Stent.
•Estimated life expectancy ≥1 year.
•Patient is ambulatory (use of assistive walking device such as a cane or walker is acceptable).
•Patient has adequate inflow to the target lesion(s), per investigator/sub-investigator discretion, involving at least a patent femoral or deep femoral vein.
•Presence of non-malignant symptomatic unilateral iliofemoral venous obstruction.
•Presence of non-malignant unilateral obstruction of the common femoral vein, external iliac vein, and/or common iliac vein defined as occlusion or at least 50% reduction in target vessel lumen as measured by procedural IVUS and venogram.
+7 more criteria

Exclusion Criteria

•Patient has DVT in the target areas with symptom onset date greater than 14 days but less than or equal to 90 days prior to treatment.
•Patient is a pregnant or breastfeeding woman, or a woman planning to become pregnant through the 12-month visit.
•Patient has clinically significant (e.g., symptoms of chest pain, hemoptysis, dyspnea, hypoxia, etc.) pulmonary embolism (confirmed via Computed Tomography Angiography) at the time of enrollment.
•Patient has a known uncorrectable bleeding diathesis or active coagulopathy meeting the following definitions (all must be tested for):
•1. uncorrected INR\>2 (not as a result of warfarin or DOAC therapy), OR
•2. platelet count \<50,000 or \>1,000,000 cells/mm3, OR
•3. white blood cell count \<3,000 or \>12,500 cells/mm3
•Patient has impaired renal function (eGFR \<30 mL/min/1.73m2) or is currently on dialysis.
•Patient has uncorrected hemoglobin of \<9 g/dL.
•Patient has known history of antiphospholipid syndrome (APS).
+14 more criteria

Locations (27)

Stanford University School of Medicine

Stanford, California, United States

Advanced Heart and Vein (ClinRe)

Thornton, Colorado, United States

Vascular Care Group

Darien, Connecticut, United States

Yale University

New Haven, Connecticut, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Manatee Memorial Hospital

Bradenton, Florida, United States

Northwestern University

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Vascular Care Group

Wellesley, Massachusetts, United States

University of Michigan Hospital

Ann Arbor, Michigan, United States

Key Dates

Start Date

March 2, 2023

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2031

Last Updated

November 24, 2025

Enrollment

165

ESTIMATED participants

Conditions

Venous ThrombosesVenous DiseaseVenous Leg UlcerVenous StasisVenous UlcerVenous StenosisVenous OcclusionVein ThrombosisVein OcclusionVein Disease

Interventions

GORE® VIAFORT Vascular Stent

DEVICE

Contacts

Carl Conway

CONTACT

6175952277 cconway@wlgore.com

Leonard Resecker

CONTACT

62356520649287074940 lresecke@wlgore.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study

Inclusion Criteria

Exclusion Criteria

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