The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study

NCT05409976 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: VNS 21-05
• Study Type: interventional
• Target: 136
• Locations: 7 countries
• Sites: 17

Brief 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

Vein Disease; Venous Leg Ulcer; Venous Stasis; Venous Stenosis; Venous Occlusion; Vein Thrombosis; Vein Occlusion; Venous Thromboses; Venous Disease; Venous Ulcer

Keywords

VIAFORT; Vein Stent; Venous Thrombosis; Venous Stenosis; Gore; Venous occlusion; VIABAHN FORTEGRA; FORTEGRA; Venous Disease; Deep Venous Insufficiency; Deep venous; DVT Treatment; Venous Stent; Venous insufficiency treatment options; Venous disease treatment Options

Outcome Measures

Primary Outcomes (2)

• Initial Subject Analysis Population: Percentage of Subjects With Freedom From the Composite Endpoint of Effectiveness and Safety Events

  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

  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 Outcomes (17)

• Number of Subjects With Primary Patency as Confirmed by Imaging and Adverse Events

  60 months

• Number of Subjects With Secondary Patency as Confirmed by Imaging and Adverse Events

  60 months

• Number of Subjects With Clinically Driven Target Lesion Revascularization as Confirmed by Imaging and Adverse Events

  60 months

• Number of Subjects With Device Fracture as Confirmed With Imaging

  60 months

• Number of Subjects With Stent Embolization as Confirmed With Imaging

  12 months

Study Arms (1)

GORE® VIAFORT Vascular Stent

EXPERIMENTAL

GORE® VIAFORT Vascular Stent

Device: GORE® VIAFORT Vascular Stent

Interventions

GORE® VIAFORT Vascular Stent DEVICE

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

GORE® VIAFORT Vascular Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (17)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Northwestern

Chicago, Illinois, 60611, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Atrium Health-Sanger Heart and Vascular Institute

Charlotte, North Carolina, 28204, United States

Location

Sentara

Norfolk, Virginia, 23507, United States

Location

Flinders Medical Centre

Adelaide, South Australia, 5042, Australia

Location

Universitätsklinikum Aachen

Aachen, 52074, Germany

Location

Alexianer Klinikum Hochsauerland GmbH

Arnsberg, 59759, Germany

Location

University College Hospital GALWAY /Clinical Research Facility Galway

Galway, Connacht, H91 YR71, Ireland

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Hesperia Hospital

Modena, 41125, Italy

Location

Auckland City Hospital

Auckland, New Zealand

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Venous Thrombosis; Varicose Ulcer

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Varicose Veins; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Austin Phillips
• Organization: W. L. Gore & Associates

agphilli@wlgore.com

+19288643641

Study Officials

• Kush Desai, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Stephen Black, MD, FRCS (Ed), FEBVS

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a prospective, multicenter, non-randomized, single-arm study.

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: June 8, 2022
• Study Start: October 25, 2022
• Primary Completion (Estimated): May 9, 2026
• Study Completion (Estimated): May 9, 2030
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1); DE (2); US (8); IT (2); NZ (1); GB (2); AU (1)