RECRUITING

The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study

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Conditions

Venous ThrombosesVenous DiseaseVenous Leg UlcerVenous StasisVenous UlcerVenous StenosisVenous OcclusionVein ThrombosisVein OcclusionVein DiseaseVIAFORTVein StentVenous ThrombosisGoreFORTEGRAVIABAHN FORTEGRADeep Venous InsufficiencyVenous disease treatment OptionsDeep venousDVT TreatmentVenous StentVenous insufficiency treatment options

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-02
Study Completion:2031-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05489588

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient is at least 18 years of age.
  2. * Patient is willing and able to comply with all follow-up evaluations as well as any required medication or compression regimen.
  3. * Patient is able to provide informed consent.
  4. * One of the following: Clinical severity class of CEAP 'C' classification ≥3 or rVCSS pain score ≥2.
  5. * Intention to treat the target areas with only the GORE® VIAFORT Vascular Stent.
  6. * Estimated life expectancy ≥1 year.
  7. * Patient is ambulatory (use of assistive walking device such as a cane or walker is acceptable).
  8. * Patient has adequate inflow to the target lesion(s), per investigator/sub-investigator discretion, involving at least a patent femoral or deep femoral vein.
  9. * Presence of non-malignant symptomatic unilateral iliofemoral venous obstruction.
  1. * 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.
  2. * Patient is a pregnant or breastfeeding woman, or a woman planning to become pregnant through the 12-month visit.
  3. * 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.
  4. * Patient has a known uncorrectable bleeding diathesis or active coagulopathy meeting the following definitions (all must be tested for):
  5. 1. uncorrected INR\>2 (not as a result of warfarin or DOAC therapy), OR
  6. 2. platelet count \<50,000 or \>1,000,000 cells/mm3, OR
  7. 3. white blood cell count \<3,000 or \>12,500 cells/mm3
  8. * Patient has impaired renal function (eGFR \<30 mL/min/1.73m2) or is currently on dialysis.
  9. * Patient has uncorrected hemoglobin of \<9 g/dL.
  10. * Patient has known history of antiphospholipid syndrome (APS).
  11. * Patient has known homozygous or acquired coagulation defect (e.g., Protein C or Protein S deficiency) that cannot be treated with therapeutic anticoagulation.
  12. * 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.
  13. * Patient has had or requires open deep venous surgery in the target limb.
  14. * 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.
  15. * Patient has had a previous major (i.e., above the ankle) amputation of the target lower limb.
  16. * Patient has known sensitivity to device materials.
  17. * Patient has had prior stenting or grafts in the target vessels.
  18. * 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.
  19. * Patient has known history of intravenous drug abuse within one year of treatment.
  20. * Patient has significant peripheral arterial disease (chronic Rutherford Type 2 or greater, acute Rutherford Type IIa or greater).
  21. * 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.
  22. * Patient is actively undergoing or plans to begin cancer treatment.
  23. * Patients with hypercoagulable states that are unwilling to take anticoagulant medications on a long-term basis.
  24. * Patient has contraindication to thrombolytics, anticoagulants, or iodinated contrast necessary for the index procedure and long-term medical therapy (contrast pre-medication is acceptable).

Contacts and Locations

Study Contact

Carl Conway
CONTACT
6175952277
cconway@wlgore.com
Leonard Resecker
CONTACT
62356520649287074940
lresecke@wlgore.com

Principal Investigator

Kush Desai, MD
PRINCIPAL_INVESTIGATOR
Northwestern University
Kathleen Gibson, MD
PRINCIPAL_INVESTIGATOR
Lake Washington Vascular Surgeons

Study Locations (Sites)

Stanford University School of Medicine
Stanford, California, 94305
United States
Advanced Heart and Vein (ClinRe)
Thornton, Colorado, 80023
United States
Vascular Care Group
Darien, Connecticut, 06820
United States
Yale University
New Haven, Connecticut, 06519
United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
Manatee Memorial Hospital
Bradenton, Florida, 34208
United States
Northwestern University
Chicago, Illinois, 60611
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Vascular Care Group
Wellesley, Massachusetts, 02482
United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109
United States
Englewood Hospital & Med Center
Englewood, New Jersey, 07631
United States
Holy Name Medical Center
Teaneck, New Jersey, 07666
United States
Mount Sinai Medical Center
New York, New York, 10029
United States
Stony Brook
Stony Brook, New York, 11790
United States
St. Peter's Vascular Associates
Troy, New York, 12180
United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Atrium Health-Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204
United States
NC Heart and Vascular Research
Raleigh, North Carolina, 27519
United States
Bethesda North
Cincinnati, Ohio, 45242
United States
University Hospitals Cleveland
Cleveland, Ohio, 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 14213
United States
The Miriam Hospital
Providence, Rhode Island, 02906
United States
UT Southwestern
Dallas, Texas, 75390
United States
Sentara General Hospital
Norfolk, Virginia, 23507
United States
Overlake Hospital
Bellevue, Washington, 98004
United States
Medical College of Wisconsin - Froedtert Hospital
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: W.L.Gore & Associates

  • Kush Desai, MD, PRINCIPAL_INVESTIGATOR, Northwestern University
  • Kathleen Gibson, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2023-03-02
Study Completion Date2031-03

Study Record Updates

Study Start Date2023-03-02
Study Completion Date2031-03

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

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