The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study

NCT05489588 | Recruiting DMC FDA Device

• 1 other identifier: VNS 21-07
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Composite of safety events

  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

  Rate of subjects with primary patency as confirmed by imaging and adverse events

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

You may not qualify if:

• 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):
• 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).
• 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.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (27)

Stanford University School of Medicine

Stanford, California, 94305, United States

RECRUITING

Advanced Heart and Vein (ClinRe)

Thornton, Colorado, 80023, United States

WITHDRAWN

Vascular Care Group

Darien, Connecticut, 06820, United States

RECRUITING

Yale University

New Haven, Connecticut, 06519, United States

RECRUITING

MedStar Washington Hospital Center

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

RECRUITING

Manatee Memorial Hospital

Bradenton, Florida, 34208, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Vascular Care Group

Wellesley, Massachusetts, 02482, United States

RECRUITING

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

RECRUITING

Englewood Hospital & Med Center

Englewood, New Jersey, 07631, United States

RECRUITING

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

WITHDRAWN

Mount Sinai Medical Center

New York, New York, 10029, United States

RECRUITING

Stony Brook

Stony Brook, New York, 11790, United States

RECRUITING

St. Peter's Vascular Associates

Troy, New York, 12180, United States

RECRUITING

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Atrium Health-Sanger Heart and Vascular Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

NC Heart and Vascular Research

Raleigh, North Carolina, 27519, United States

RECRUITING

Bethesda North

Cincinnati, Ohio, 45242, United States

RECRUITING

University Hospitals Cleveland

Cleveland, Ohio, 44106, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 14213, United States

RECRUITING

The Miriam Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

UT Southwestern

Dallas, Texas, 75390, United States

RECRUITING

Sentara General Hospital

Norfolk, Virginia, 23507, United States

RECRUITING

Overlake Hospital

Bellevue, Washington, 98004, United States

RECRUITING

Medical College of Wisconsin - Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

RECRUITING

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

Study Officials

• Kush Desai, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Kathleen Gibson, MD

  Lake Washington Vascular Surgeons

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carl Conway

CONTACT

6175952277; cconway@wlgore.com

Leonard Resecker

CONTACT

62356520649287074940; lresecke@wlgore.com

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: August 2, 2022
• First Posted: August 5, 2022
• Study Start: March 2, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): March 1, 2031
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)