The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
W.L.Gore & Associates
Study ID
NCT05811364
Status
Recruiting
Apply to this trial

Conditions

  • Aortoiliac Occlusive Disease
  • Peripheral Arterial Disease

Eligibility Criteria

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

Interventions

  • Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis — DEVICE
    Treatment of target lesions in the common and/or external iliac arteries by stenting with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.
  • Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent — DEVICE
    Treatment of target lesions in the common and/or external iliac arteries by stenting with a commercially available bare metal stent that is approved for treatment of the disease.

Study Details

The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.

Key Dates

Start date
Oct 17, 2023
Status verified
May 2026
Primary completion
Mar 30, 2028
Completion
Jan 31, 2032

Study Design

Enrollment
244 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: VBX Device Group
    Subject in this group will receive treatment with the GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
  • Active Comparator: BMS Control Group
    Subjects in this group will receive treatment with a commercially available bare metal stent (BMS) that is approved for treatment of the disease

Primary Outcome Measure

Primary Patency [ Time Frame: 1 year ]

Central Contacts

Locations (26)

FacilityCityStateZIPSite coordinators
Central Arkansas Veterans Healthcare SystemLittle RockArkansas72205-
VA Long Beach Healthcare SystemLong BeachCalifornia90822
Anthony Chau, MD
Denver Health and Hospital AuthorityDenverColorado80204
Lisa Bennett, MD
North Suburban Medical CenterDenverColorado80229-
University of Florida - GainesvilleGainesvilleFlorida32608
Samir Shah, MD
Radiology and Imaging Specialists of LakelandLakelandFlorida33801
Fakhir Elmasri, MD
University of South FloridaTampaFlorida33620
Sashi Inkollu, MD
Atlanta VA Medical CenterDecaturGeorgia30033
Olamine Alabi, MD
Louisiana State University Health Sciences CenterNew OrleansLouisiana70112
Malachi Sheahan, MD
Beth Israel Deaconess Medical Center, Inc.BostonMassachusetts02215
Mark Wyers, MD
Corewell Health SystemGrand RapidsMichigan49503
Andrew Kimball, MD
The Curators of the University of MissouriColumbiaMissouri65212
Jonathan Bath, MD
Research Foundation SUNY BuffaloAmherstNew York14228-
Trinity Medical CenterBuffaloNew York14214
Aimee Swartz, MD
VA Western New York Healthcare SystemBuffaloNew York14215
Hasan Dosluoglu, MD
Mt. Sinai Medical CenterNew YorkNew York10029
Prakash Krishnan, MD
New York University School of MedicineNew YorkNew York10016
Karan Garg, MD
Atrium HealthCharlotteNorth Carolina28210
Hector Crespo-Soto, MD
University Hospitals - Cleveland Medical CenterAshlandOhio44805
Yulanka Castro-Dominguez, MD
Cleveland Clinic FoundationClevelandOhio44195
Levester Kirksey, MD
Portland Health Care System VAPortlandOregon97239
Harish Krishnamoorthi, MD
Providence Heart & Vascular InstituteWilsonvilleOregon97070
Brant Ullery, MD
University of PennsylvaniaPhiladelphiaPennsylvania19104
Grace Wang, MD
Wellmont Holston Valley Medical CenterKingsportTennessee37660
Christopher Metzger, MD
The University of Texas Southwestern Medical CenterDallasTexas75390
Melissa Kirkwood, MD
Sentara Medical GroupNorfolkVirginia23507
David Dexter, MD

Find similar trials in Little Rock, AR

By research site
Central Arkansas Veterans Healthcare System· Little Rock, ARVA Long Beach Healthcare System· Long Beach, CADenver Health and Hospital Authority· Denver, CONorth Suburban Medical Center· Denver, COUniversity of Florida - Gainesville· Gainesville, FLRadiology and Imaging Specialists of Lakeland· Lakeland, FL

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