The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study

April 8, 2026 updated by: W.L.Gore & Associates

Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Inferior Vena Cava Obstruction With or Without Combined Iliofemoral Obstruction

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A maximum of 35 clinical investigative sites across the U.S., Europe, Australia, and New Zealand will participate in this study. One hundred and eleven 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 22 treated subjects per site and a minimum of 45 patients treated within the United States. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5042
        • Flinders Medical Centre
  • Germany
      • Aachen, Germany, 52074
        • Universitätsklinikum Aachen
      • Arnsberg, Germany, 59759
        • Alexianer Klinikum Hochsauerland GmbH
  • Ireland
    • Connacht
      • Galway, Connacht, Ireland, H91 YR71
        • University College Hospital GALWAY /Clinical Research Facility Galway
  • Italy
      • Milan, Italy, 20132
        • Ospedale San Raffaele
      • Modena, Italy, 41125
        • Hesperia Hospital
  • New Zealand
      • Auckland, New Zealand
        • Auckland City Hospital
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
      • London, United Kingdom, SE1 7EH
        • St Thomas' Hospital
  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Medstar Washington Hospital Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Atrium Health-Sanger Heart and Vascular Institute
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Preoperative 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.

Preoperative Exclusion Criteria:

  • Patient is a pregnant or breastfeeding woman, a woman planning to become pregnant through the 12-month visit, or a woman who is unwilling to practice an acceptable method of preventing pregnancy 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: uncorrected INR>2 (not as a result of warfarin or DOAC therapy), OR platelet count <50,000 or >1,000,000 cells/mm3, OR 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) or patients with hypercoagulable states that are unwilling to take anticoagulant medications on a long-term basis.
  • Patient has known homozygous inherited coagulation defect or Protein C/S deficiency.
  • Patient has a planned surgical intervention (other than pre-stenting procedures such as thrombolysis or thrombectomy) within 30 days prior to or within 30 days after the planned study procedure.
  • Patient is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this treatment, in the opinion of the investigator/sub-investigator. Observational studies are permitted.
  • Patient has had a previous major (i.e., above the ankle) amputation of the target lower limb.
  • Patient has known sensitivity to device materials or contraindication to antiplatelets, thrombolytics, anticoagulants (including patients with known prior instances of Heparin Induced Thrombocytopenia type 2 (HIT-2)), or iodinated contrast.
  • Patient has had prior stenting or grafts in the target vessels.
  • Patient has a known or suspected active systemic infection at the time of the index procedure. Patients with a chronic infection (e.g., HIV, hepatitis C) that is well controlled under their current treatment regimen may be eligible.
  • Patient has known history of intravenous drug abuse within one year of treatment.
  • Patient has significant peripheral arterial disease (chronic Rutherford Type 2 or greater, acute Rutherford Type IIa or greater).
  • Patient has a BMI >40.
  • Patient is actively undergoing or plans to begin cancer treatment.

Intraoperative Inclusion Criteria:

  • Presence of non-malignant obstruction of the inferior vena cava defined as occlusion or at least 50% reduction in target vessel lumen as measured by procedural IVUS and venogram, with or without non-malignant obstruction of the common femoral vein, external iliac vein, and/or common iliac vein.
  • Patient can accommodate an appropriately sized GORE® VIAFORT Vascular Stent as per reference vessel diameter (see IFU), as determined by intraoperative IVUS post pre-dilation.
  • Patient must have appropriate access vessels to accommodate the delivery sheath for the selected device size.
  • Patient has adequate landing zones free from significant disease requiring treatment within the native vessels beyond the proximal and distal margins of the lesion.
  • Patient has adequate inflow to the target lesion(s), per investigator/sub-investigator discretion, involving at least a patent femoral or deep femoral vein.
  • Lesion can be traversed with a guidewire.
  • Disease involves the inferior vena cava and may include iliofemoral segments with intent to stent all affected iliofemoral and caval segments.
  • 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.
  • Patient does not have an inferior vena cava filter present within the target stent area at the time of investigational device placement. Patients with an inferior vena cava filter present within the target stent area must have the filter successfully removed prior to investigational device placement. Successful removal is defined as removal of the main body of the filter and intra-luminal fragments such that there is minimal risk to luminal integrity per investigator/sub-investigator discretion AND freedom from bleeding, vascular injury, or hemodynamically significant pulmonary embolism. After successful filter removal, investigational device placement can occur within the same procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GORE® VIAFORT Vascular Stent
Device: GORE® VIAFORT Vascular Stent
Treatment of symptomatic IVC obstruction with or without combined iliofemoral obstruction with the GORE® VIAFORT Vascular Stent.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Initial Subject Analysis Population: Percentage of Subjects With Freedom From the Composite Endpoint of Effectiveness and Safety Events
Time Frame: 12 months

Composite primary endpoint consisting of freedom from the following:

  • Loss of primary patency through 12-month follow-up
  • Stent embolization through 12-month follow-up
  • Device- or procedure-related death through 30 days
  • Clinically significant pulmonary embolism confirmed via Computed Tomography Angiography through 30 days
  • Device- or procedure-related vascular injury through 30 days requiring surgical or endovascular intervention
  • Device- or procedure-related major bleeding events through 30 days
12 months
Global Analysis Population: Percentage of Subjects With Freedom From the Composite Endpoint of Effectiveness and Safety Events
Time Frame: 12 months

Composite primary endpoint consisting of freedom from the following:

  • Loss of primary patency through 12-month follow-up
  • Stent embolization through 12-month follow-up
  • Device- or procedure-related death through 30 days
  • Clinically significant pulmonary embolism confirmed via Computed Tomography Angiography through 30 days
  • Device- or procedure-related vascular injury through 30 days requiring surgical or endovascular intervention
  • Device- or procedure-related major bleeding events through 30 days
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Revised Venous Clinical Severity Scale (rVCSS)
Time Frame: 60 months

Change in Revised Venous Clinical Severity Scale (rVCSS) Measurement through 60-month follow-up compared to baseline prior to treatment.

Note: The rVCSS scale ranges from 0 to 30, with higher scores reflecting worse symptoms.
60 months
Revised Venous Clinical Severity Scale (rVCSS) Pain
Time Frame: 60 months

Change in Revised Venous Clinical Severity Scale (rVCSS) Pain Measurement through 60-month follow-up compared to baseline prior to treatment.

Note: The rVCSS Pain scale ranges from 0 to 3, with higher scores reflecting worse pain.
60 months
Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) VEINES-QOL/Sym
Time Frame: 60 months
Change in Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) Measurement through 60-month follow-up compared to baseline prior to treatment.
60 months
Villalta
Time Frame: 60 months
Change in Villalta Measurement through 60-month follow-up compared to baseline prior to treatment.
60 months
5 Level EuroQol-5 Dimension (EQ-5D-5L)
Time Frame: 60 months
Change in 5 Level EuroQol-5 Dimension (EQ-5D-5L) Measurement through 60-month follow-up compared to baseline prior to treatment.
60 months
Number of Subjects With Primary Patency as Confirmed by Imaging and Adverse Events
Time Frame: 60 months

Number of subjects with freedom from both:

  • stent occlusion due to restenosis or thrombosis as confirmed with imaging, and
  • clinically driven target lesion revascularization as confirmed with imaging and adverse events
60 months
Number of Subjects With Secondary Patency as Confirmed by Imaging and Adverse Events
Time Frame: 60 months
Number of subjects with freedom from permanent loss of blood flow through the device, regardless of reintervention.
60 months
Number of Subjects With Clinically Driven Target Lesion Revascularization as Confirmed by Imaging and Adverse Events
Time Frame: 60 months
Number of subjects with repeat endovascular procedures (e.g., PTA, stenting, thrombectomy/thrombolysis) to restore flow, performed within the margins of the investigational devices due to ≥50% restenosis of the target lesion as measured via imaging AND the failure to improve or recurrence of venous origin leg pain or venous edema related to the target lesion present at baseline, or the onset of new symptoms including venous origin pain and venous edema related to the target lesion.
60 months
Number of Subjects With Device Fracture as Confirmed With Imaging
Time Frame: 60 months
Number of subjects with device fracture as confirmed with imaging.
60 months
Number of Subjects With Stent Embolization as Confirmed With Imaging
Time Frame: 12 months
Number of subjects with stent embolization as confirmed with imaging.
12 months
Number of Subjects With Device- or Procedure-related Death
Time Frame: 30 days
Number of subjects with device- or procedure-related death.
30 days
Number of Subjects With Clinically Significant Pulmonary Embolism as Confirmed With Imaging and Adverse Events
Time Frame: 30 days
Number of subjects with clinically significant pulmonary embolism confirmed via Computed Tomography Angiography through 30 days.
30 days
Number of Subjects With Device- or Procedure-related Vascular Injury as Confirmed With Adverse Events
Time Frame: 30 days
Number of subjects with device- or procedure-related vascular injury through 30 days requiring surgical or endovascular intervention.
30 days
Number of Subjects With Device- or Procedure-related Major Bleeding Events as Confirmed With Adverse Events
Time Frame: 30 days
Number of subjects with device- or procedure-related major bleeding events through 30 days.
30 days
Technical Success
Time Frame: Index procedure (post-op day 0)
Number of subjects with successful delivery and deployment of the stent to the intended location, and removal of delivery system.
Index procedure (post-op day 0)
Lesion Success
Time Frame: Index procedure (post-op day 0)
Number of subjects with evidence of ≤50% residual stenosis at the conclusion of the index procedure as measured by IVUS or venogram.
Index procedure (post-op day 0)
Procedural Success
Time Frame: Index procedure through hospital discharge (discharge estimated as up to 30 days post-treatment)
Number of subjects with lesion success and the absence of major adverse events (i.e., stent embolization, device- or procedure-related death, clinically significant pulmonary embolism, device- or procedure-related vascular injury requiring surgical or endovascular intervention, and device- or procedure-related major bleeding) prior to discharge.
Index procedure through hospital discharge (discharge estimated as up to 30 days post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
W.L.Gore & Associates

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kush Desai, MD, Northwestern University
  • Principal Investigator: Stephen Black, MD, FRCS (Ed), FEBVS, Guy's and St Thomas' NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 9, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 9, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VNS 21-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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