The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study

Part of paid clinical trials in Stanford, California.

Sponsor
W.L.Gore & Associates
Study ID
NCT05489588
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 unilateral symptomatic iliofemoral venous obstruction with the GORE® VIAFORT Vascular Stent.

Study Details

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.

Key Dates

First listed
Aug 5, 2022
Start date
Mar 2, 2023
Status verified
Aug 2026
Primary completion
Aug 31, 2027
Completion
Mar 31, 2031

Study Design

Enrollment
165 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Composite of safety events [ Time Frame: 12 months (Stent Embolization) or 30 days (all other components) ]

Locations (24)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305-
Vascular Care GroupDarienConnecticut06820-
Yale UniversityNew HavenConnecticut06519-
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010-
Manatee Memorial HospitalBradentonFlorida34208-
Northwestern UniversityChicagoIllinois60611-
Massachusetts General HospitalBostonMassachusetts02114-
Vascular Care GroupWellesleyMassachusetts02482-
University of Michigan HospitalAnn ArborMichigan48109-
Englewood Hospital & Med CenterEnglewoodNew Jersey07631-
Mount Sinai Medical CenterNew YorkNew York10029-
Stony BrookStony BrookNew York11790-
University of North Carolina - Chapel HillChapel HillNorth Carolina27599-
Atrium Health-Sanger Heart and Vascular InstituteCharlotteNorth Carolina28204-
NC Heart and Vascular ResearchRaleighNorth Carolina27519-
Bethesda NorthCincinnatiOhio45242-
Cleveland Clinic FoundationClevelandOhio44195-
University Hospitals ClevelandClevelandOhio44106-
University of Pittsburgh Medical CenterPittsburghPennsylvania14213-
The Miriam HospitalProvidenceRhode Island02906-
UT SouthwesternDallasTexas75390-
Sentara General HospitalNorfolkVirginia23507-
Overlake HospitalBellevueWashington98004-
Medical College of Wisconsin - Froedtert HospitalMilwaukeeWisconsin53226-

Find similar trials in Stanford, CA

By research site
Stanford University School of Medicine· Stanford, CAVascular Care Group· Darien, CTYale University· New Haven, CTMedStar Washington Hospital Center· Washington D.C., DCManatee Memorial Hospital· Bradenton, FLNorthwestern University· Chicago, IL

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