The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study

April 7, 2026 updated by: W.L.Gore & Associates

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

165

Phase

  • 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 Backup

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University School of Medicine
        • Sub-Investigator:
          • William Kuo, MD
        • Sub-Investigator:
          • Andrew Picel, MD
        • Principal Investigator:
          • Andrew Kesselman, MD
        • Sub-Investigator:
          • Alex Vezeridis, MD
        • Sub-Investigator:
          • Lawrence Hofmann, Md
        • Contact:
        • Sub-Investigator:
          • Mona Ranade, MD
    • Colorado
      • Thornton, Colorado, United States, 80023
        • Withdrawn
        • Advanced Heart and Vein (ClinRe)
    • Connecticut
      • Darien, Connecticut, United States, 06820
        • Recruiting
        • Vascular Care Group
        • Sub-Investigator:
          • Edward Arous, MD
        • Sub-Investigator:
          • Naiem Nassiri, MD
        • Contact:
        • Principal Investigator:
          • Paul Gagne, MD
        • Sub-Investigator:
          • Chong Li, MD
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale University
        • Principal Investigator:
          • Cassius Chaar, MD
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center
        • Principal Investigator:
          • Steven Abramowitz, MD
        • Sub-Investigator:
          • Danielle Salazar, MD
        • Sub-Investigator:
          • Kyle Reynolds, MD
        • Sub-Investigator:
          • Misaki Kiguchi, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Saher Sabri, MD
    • Florida
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Kush Desai, MD
        • Sub-Investigator:
          • Ramona Gupta, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Julianne Stoughton, MD
        • Sub-Investigator:
          • Luis Suarez, MD
        • Sub-Investigator:
          • Abhisekh Mohapatra, MD
        • Sub-Investigator:
          • Nikolaos Zacharias, MD
        • Sub-Investigator:
          • Jahan Mohabeli, MD
        • Contact:
      • Wellesley, Massachusetts, United States, 02482
        • Recruiting
        • Vascular Care Group
        • Sub-Investigator:
          • Daniel Gorin, MD
        • Sub-Investigator:
          • Christopher Kwolek, MD
        • Sub-Investigator:
          • Stratton Danes, MD
        • Sub-Investigator:
          • Scott James, MD
        • Contact:
        • Principal Investigator:
          • Todd Lancaster, MD
        • Sub-Investigator:
          • Elizabeth Blazick, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Hospital
        • Sub-Investigator:
          • Daniel Kirkpatrick, MD
        • Contact:
        • Sub-Investigator:
          • Amber Liles, MD
        • Sub-Investigator:
          • David Williams, MD
        • Principal Investigator:
          • William Sherk, MD
        • Sub-Investigator:
          • Minhajuddin Khaja, MD
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Recruiting
        • Englewood Hospital & Med Center
        • Principal Investigator:
          • Steven Elias, MD
        • Contact:
      • Teaneck, New Jersey, United States, 07666
        • Withdrawn
        • Holy Name Medical Center
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Medical Center
        • Principal Investigator:
          • Windsor Ting, MD
        • Contact:
        • Sub-Investigator:
          • Ajit Rao, MD
      • Stony Brook, New York, United States, 11790
      • Troy, New York, United States, 12180
        • Recruiting
        • St. Peter's Vascular Associates
        • Principal Investigator:
          • Kathleen Ozsvath, MD
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina - Chapel Hill
        • Principal Investigator:
          • Katharine McGinigle, MD
        • Contact:
        • Sub-Investigator:
          • William Marston, MD
        • Sub-Investigator:
          • Nicole Keefe, MD
        • Contact:
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Atrium Health-Sanger Heart and Vascular Institute
        • Principal Investigator:
          • Erin Murphy, MD
        • Contact:
        • Sub-Investigator:
          • Frank Arko, MD
        • Sub-Investigator:
          • Hector Crespo-Soto, MD
      • Raleigh, North Carolina, United States, 27519
        • Recruiting
        • NC Heart and Vascular Research
        • Principal Investigator:
          • Robert Mendes, MD
        • Sub-Investigator:
          • Jason Kim, MD
        • Sub-Investigator:
          • Martyn Knowles, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Bethesda North
        • Principal Investigator:
          • Patrick Muck, MD
        • Contact:
        • Sub-Investigator:
          • Mark Broering, MD
        • Contact:
        • Sub-Investigator:
          • Adam Reichard, MD
        • Sub-Investigator:
          • Aaron Kulwicki, MD
        • Sub-Investigator:
          • Matt Recht, MD
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Sub-Investigator:
          • Sean Lyden, MD
        • Principal Investigator:
          • Jon Quatromoni, MD
        • Sub-Investigator:
          • Francis Caputo, MD
        • Sub-Investigator:
          • Ali Khalifeh, MD
        • Sub-Investigator:
          • Levester Kirksey, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • David Laczynski, MD
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland
        • Principal Investigator:
          • Karem Harth, MD
        • Sub-Investigator:
          • Yulanka Castro-Dominguez, MD
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 14213
        • Recruiting
        • University of Pittsburgh Medical Center
        • Sub-Investigator:
          • Michael Singh, MD
        • Contact:
        • Sub-Investigator:
          • Eric Hager, MD
        • Sub-Investigator:
          • Nathan Liang, MD
        • Contact:
        • Principal Investigator:
          • Natalie Sridharan, MD
        • Sub-Investigator:
          • Raymond Eid, MD
        • Sub-Investigator:
          • Theodore Yuo, MD
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Recruiting
        • The Miriam Hospital
        • Sub-Investigator:
          • Peter Soukas, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pieter de Klerk, MD
    • Texas
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara General Hospital
        • Contact:
        • Principal Investigator:
          • David Dexter, MD
    • Washington
      • Bellevue, Washington, United States, 98004
        • Recruiting
        • Overlake Hospital
        • Sub-Investigator:
          • Renee Minjarez, MD
        • Sub-Investigator:
          • Elica Inagaki, MD
        • Principal Investigator:
          • Kathleen Gibson, MD
        • Contact:
        • Sub-Investigator:
          • Sooyeon Kim, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin - Froedtert Hospital
        • Sub-Investigator:
          • Matthew Scheidt, MD
        • Principal Investigator:
          • Parag Patel, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Eric Hohenwalter, MD
        • Sub-Investigator:
          • Mustafa Haddad, MD
        • Sub-Investigator:
          • Kalla Tremblay, MD

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

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.
  • Presence of non-malignant symptomatic unilateral iliofemoral venous obstruction.

Preoperative 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).
  • Patient has known homozygous or acquired coagulation defect (e.g., Protein C or Protein S deficiency) that cannot be treated with therapeutic anticoagulation.
  • Patient has a planned surgical intervention that has the potential to clinically interfere with the endpoints of this treatment (other than pre-stenting procedures such as thrombolysis or thrombectomy) within 30 days prior to or within 30 days after the planned study procedure. Examples include surgical interventions that may impact mobility, and surgical interventions that require cessation of therapeutic antiplatelet or anticoagulation within 30 days following the index procedure.
  • Patient has had or requires open deep venous surgery in the target limb.
  • 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.
  • 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 can be managed, and with an active clinical plan in place 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 >45. Patients with a BMI of up to 45 may be enrolled provided that diagnostic quality ultrasound of the implant sites can be performed.
  • Patient is actively undergoing or plans to begin cancer treatment.
  • Patients with hypercoagulable states that are unwilling to take anticoagulant medications on a long-term basis.
  • Patient has contraindication to thrombolytics, anticoagulants, or iodinated contrast necessary for the index procedure and long-term medical therapy (contrast pre-medication is acceptable).

Intraoperative Inclusion Criteria:

  • 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 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 only unilateral iliofemoral venous segments with intent to stent all affected iliofemoral segments. 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 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.

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
Intervention / Treatment
Experimental: GORE® VIAFORT Vascular Stent
Device: GORE® VIAFORT Vascular Stent
Treatment of unilateral symptomatic iliofemoral venous obstruction with the GORE® VIAFORT Vascular Stent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of safety events
Time Frame: 12 months (Stent Embolization) or 30 days (all other components)

Composite primary safety endpoint consisting of freedom from the following:

  • 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 day
12 months (Stent Embolization) or 30 days (all other components)
Primary efficacy as assessed by primary patency
Time Frame: 12 months
Rate of subjects with primary patency as confirmed by imaging and adverse events
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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 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
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
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)
Number of subjects with secondary patency as confirmed by imaging and adverse events
Time Frame: 60 months
Freedom from permanent loss of blood flow through the device, regardless of reintervention.
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

Collaborators and Investigators

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

Sponsor

W.L.Gore & Associates

Investigators

  • Principal Investigator: Kush Desai, MD, Northwestern University
  • Principal Investigator: Kathleen Gibson, MD, Lake Washington Vascular Surgeons

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)

March 2, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

March 1, 2031

Study Registration Dates

First Submitted

August 2, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 5, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VNS 21-07

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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