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
Start Date
10/17/2023
Completion Date
1/31/2032
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent
Conditions
Locations
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas 72205
United States
VA Long Beach Healthcare System
Long Beach, California 90822
United States
Denver Health and Hospital Authority
Denver, Colorado 80204
United States
North Suburban Medical Center
Denver, Colorado 80229
United States
University of Florida - Gainesville
Gainesville, Florida 32608
United States
Radiology and Imaging Specialists of Lakeland
Lakeland, Florida 33801
United States
University of South Florida
Tampa, Florida 33620
United States
Atlanta VA Medical Center
Decatur, Georgia 30033
United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana 70112
United States
Beth Israel Deaconess Medical Center, Inc.
Boston, Massachusetts 02215
United States
Corewell Health System
Grand Rapids, Michigan 49503
United States
The Curators of the University of Missouri
Columbia, Missouri 65212
United States
Research Foundation SUNY Buffalo
Amherst, New York 14228
United States
Trinity Medical Center
Buffalo, New York 14214
United States
VA Western New York Healthcare System
Buffalo, New York 14215
United States
New York University School of Medicine
New York, New York 10016
United States
Mt. Sinai Medical Center
New York, New York 10029
United States
Atrium Health
Charlotte, North Carolina 28210
United States
University Hospitals - Cleveland Medical Center
Ashland, Ohio 44805
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Portland Health Care System VA
Portland, Oregon 97239
United States
Providence Heart & Vascular Institute
Wilsonville, Oregon 97070
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee 37660
United States
The University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Sentara Medical Group
Norfolk, Virginia 23507
United States
Central Adelaide Local Health Network Incorporated
Adelaide,
Australia
Royal Perth Hospital
Nedlands,
Australia
Prince of Wales Hospital
Randwick,
Australia
Universitats-Herzzentrum Freiburg Bad Krozingen GmbH
Bad Krozingen,
Germany
St. Franziskus Hospital
Münster,
Germany
Krankenhaus der Barmherzigen Brüder
Regensburg,
Germany
Klinikum Stuttgart
Stuttgart,
Germany
Ospedale Niguarda Ca'Granda
Milan, MI
Italy
Ospedale Santa Maria della Misericordia
Perugia,
Italy
Azienda Complesso Ospedaliero San Filippo Neri
Roma,
Italy
Ospedale San Giovanni Molinette
Turin,
Italy
Rijnstate Hospital
Arnhem,
Netherlands
Stichting Elisabeth-TweeSteden Ziekenhuis
Tilburg,
Netherlands
Auckland City Hospital
Auckland,
New Zealand
East Kent Hospitals University NHS Foundation Trust
Canterbury,
United Kingdom
Guy's and St Thomas', NHS Foundation Trust
London,
United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton,
United Kingdom