Recruiting
Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction
What is being tested
GORE® VIAFORT Vascular Stent
Device
Who is being recruted
Cardiovascular Diseases+8
+ Leg Ulcer
+ Skin Diseases
Over 18 Years
+39 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: March 2023
Summary
Principal SponsorW.L.Gore & Associates
Study ContactCarl ConwayMore contacts
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: March 2, 2023
Actual date on which the first participant was enrolled.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.
Official TitleEvaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction
Principal SponsorW.L.Gore & Associates
Study ContactCarl ConwayMore contacts
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
165 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Cardiovascular DiseasesLeg UlcerSkin DiseasesSkin UlcerThrombosisVaricose UlcerVaricose VeinsVascular DiseasesEmbolism and ThrombosisSkin and Connective Tissue DiseasesVenous Thrombosis
Criteria
17 inclusion criteria required to participate
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.
Patient is at least 18 years of age.
One of the following: Clinical severity class of CEAP 'C' classification ≥3 or rVCSS pain score ≥2.
Patient does not have significant (i.e., >20% residual thrombosis) acute thrombus within the target stent area at the time of investigational device placement. Patients with acute thrombus within the target stent area must have thrombus successfully treated prior to investigational device placement. Successful thrombus treatment is defined as reestablishment of antegrade flow with ≤20% residual thrombosis as confirmed by IVUS and venogram, AND freedom from bleeding, vascular injury, or hemodynamically significant pulmonary embolism. After successful thrombus treatment, investigational device placement can occur within the same procedure.
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22 exclusion criteria prevent from participating
Patients with hypercoagulable states that are unwilling to take anticoagulant medications on a long-term basis.
Patients with disease extending into the inferior vena cava or contra-lateral iliofemoral veins who are anticipated to require endovascular or surgical treatment within 12 months after investigational device implant will be excluded.
Patient has impaired renal function (eGFR <30 mL/min/1.73m2) or is currently on dialysis.
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.
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGORE® VIAFORT Vascular Stent
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 27 locations
Recruiting
Stanford University School of Medicine
Stanford, United StatesOpen Stanford University School of Medicine in Google MapsRecruiting
Vascular Care Group
Darien, United StatesRecruiting
Yale University
New Haven, United StatesRecruiting
MedStar Washington Hospital Center
Washington D.C., United StatesRecruiting
27 Study Centers