The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study

Part of paid clinical trials in Stanford, California.

Sponsor
W.L.Gore & Associates
Study ID
NCT05409976
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 25, 2022
Status verified
Apr 2026
Primary completion
May 9, 2026
Completion
May 9, 2030

Study Design

Enrollment
136 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: GORE® VIAFORT Vascular Stent
    GORE® VIAFORT Vascular Stent

Primary Outcome Measure

Initial Subject Analysis Population: Percentage of Subjects With Freedom From the Composite Endpoint of Effectiveness and Safety Events [ Time Frame: 12 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305-
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010-
NorthwesternChicagoIllinois60611-
University of MichiganAnn ArborMichigan48109-
Mount Sinai Medical CenterNew YorkNew York10029-
Weill Cornell Medical CollegeNew YorkNew York10065-
Atrium Health-Sanger Heart and Vascular InstituteCharlotteNorth Carolina28204-
SentaraNorfolkVirginia23507-

Find similar trials in Stanford, CA

By research site
Stanford University School of Medicine· Stanford, CAMedStar Washington Hospital Center· Washington D.C., DCNorthwestern· Chicago, ILUniversity of Michigan· Ann Arbor, MIMount Sinai Medical Center· New York, NYWeill Cornell Medical College· New York, NY

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