1,843
Participants
Start Date
August 31, 2014
Primary Completion Date
March 1, 2022
Study Completion Date
March 1, 2022
Open surgical revascularization
Endovascular revascularization
A variety of FDA approved devices will be used within this treatment arm. The trial will submit a proof-of-concept IDE application to the FDA to cover all devices.
Auckland City Hospital, Grafton
Waikato Hospital, Hamilton
Wellington Hospital, Newtown
Mount Sinai Medical Center, New York
Columbia University Medical Center, New York
Staten Island University Hospital, Staten Island
Montefiore Medical Center, The Bronx
Westchester Medical Center, Valhalla
Albany Medical Center, Albany
Vascular Health Partners, Queensbury
SUNY Upstate Medical University, Syracuse
VA Western NY Healthcare System, Buffalo
University of Rochester Medical Center, Rochester
Allegheny General Hospital, Pittsburgh
University of Pittsburgh Medical Center, Pittsburgh
Penn State Milton S. Hershey Medical Center, Hershey
Pinnacle Health System, Wormleysburg
Temple University, Philadelphia
Medstar Washington Hospital Center, Washington D.C.
GW Medical Faculty Associates, Inc., Washington D.C.
University of Maryland Medical System, Baltimore
Johns Hopkins Hospital, Baltimore
Loyola University Medical Center, Baltimore
MedStar Union Memorial Hospital, Baltimore
Inova Fairfax Hospital, Falls Church
University of Virginia, Charlottesville
Sentara Vascular Specialists, Norfolk
CAMC Clinical Trials Center, Charleston
Wake Forest Baptist Medical Center, Winston-Salem
University of North Carolina, Chapel Hill
North Carolina Heart and Vascular Research, Raleigh
Duke University, Durham
Durham VAMC, Durham
Medical University of South Carolina, Charleston
Prisma Health-Upstate (Formerly Greenville Memorial Hospital), Greenville
Atlanta VA Medical Center, Decatur
Emory University, Atlanta
University of Florida (Gainesville), Gainesville
Mount Sinai Miami, Miami Springs
Baptist Hospital of Miami, Miami
Tampa General Hospital, Tampa
Tampa VAMC, Tampa
Florida Hospital Ocala, Ocala
The University of Alabama at Birmingham, Birmingham
Wellmont Holston Valley Medical Center, Kingsport
University of Tennessee Medical Center, Knoxville
The Ohio State University, Columbus
Ohio Health Research Institute, Columbus
University of Toledo Medical Center, Toledo
University Hospitals of Cleveland/Case Western Reserve University, Cleveland
Cleveland Clinic Foundation, Cleveland
Indiana University Medical School, Indianapolis
William Beaumont Hospital, Royal Oak
VA Ann Arbor Healthcare System, Ann Arbor
Michigan Heart/St. Joseph Mercy Ann Arbor Hospital, Ann Arbor
University of Michigan Health System, Ann Arbor
Henry Ford Health System, Detroit
Michigan Vascular Center, Flint
Spectrum Health, Grand Rapids
San Giovanni di Dio Hospital, Florence
Mercy Hospital Medical Center, West Des Moines
Medical College of Wisconsin, Milwaukee
Milwaukee VAMC, Milwaukee
University of Wisconsin-Madison, Madison
Meriter Wisconsin Heart, Madison
Gundersen Health System, La Crosse
Minneapolis Heart Hospital/Abbott Northwestern Hosp., Minneapolis
Minneapolis VAMC, Minneapolis
Mayo Clinic, Rochester
North Central Heart Institute, Sioux Falls
Loyola University Medical Center, Maywood
Central DuPage Hospital (Cadence), Chicago
Rush University Medical Center, Chicago
University of Chicago Medicine, Chicago
Decatur Memorial Hospital, Decatur
Southern Illinois University School of Medicine, Springfield
St. Louis VA Medical Center, St Louis
Midwest Aortic Vascular Institute, Kansas City
University of Missouri, Columbia
University of Nebraska Medical Center, Omaha
Ochsner Medical Center, New Orleans
University Health System: LSU Health Sciences, Shreveport
University of Arkansas for Medical Services, Little Rock
University of Oklahoma Health Sciences Center, Oklahoma City
University of Oklahoma College of Medicine at Tulsa, Tulsa
Dallas VA Medical Center, Dallas
Scott and White - Temple, Temple
Memorial Hermann Hospital TMC, Houston
Michael E. DeBakey VA Medical Center, Houston
Denver Health, Denver
University of Colorado Hospital, Aurora
Vascular Institute of the Rockies, Denver
Rocky Mountain Regional VA, Denver
The University of Utah, Salt Lake City
Arizona Heart Hospital, Phoenix
University of Arizona - Banner University Medical Center, Tucson
Carondelet Heart & Vascular Institute, Tucson
New Mexico Heart Institute, Albuquerque
New Mexico VA Medical Center, Albuquerque
Kaiser Permanente Los Angeles Medical Center, Los Angeles
VA Greater Los Angeles, Los Angeles
Keck Medical Center of USC, Los Angeles
UCLA-Gonda Vascular Surgery, Los Angeles
Harbor - UCLA Medical Center, Torrance
VA Long Beach Healthcare System, Long Beach
San Diego VAMC, La Jolla
UC San Diego Sulpizio Cardiovascular Center, La Jolla
Kaiser Permanente (San Diego), San Diego
Loma Linda University Medical Center, Loma Linda
Loma Linda VA Medical Center, Loma Linda
University of California - Irvine, Irvine
Kaiser Permanente Northern California, San Francisco
San Francisco Veterans Affairs Medical Center, San Francisco
University of California-San Francisco Medical Center, San Francisco
VA Palo Alto Health Care, Palo Alto
Stanford Hospital, Stanford
Sacramento VA Medical Center, Sacramento
University of California Davis Medical Center, Sacramento
Kaiser Foundation Hospital, Honolulu
Providence Heart and Vascular Institute, Portland
Oregon Health and Science University, Portland
Portland VA Medical Center, Portland
Benaroya Research Institute at Virginia Mason, Seattle
Harborview Medical Center, Seattle
Swedish Medical Center, Seattle
Providence Sacred Heart Medical Center, Spokane
Northwestern Memorial Hospital, Winfield
St. Francis Hospital and Medical Center, Hartford
Yale-New Haven Hospital, New Haven
West Haven VAMC, West Haven
Maine Medical Center, Portland
Massachusetts General Hospital, Boston
Brigham and Women's Hospital, Boston
Boston Medical Center, Boston
VA Boston Healthcare System, Boston
Beth Israel Deaconess Medical Center, Boston
Steward St. Elizabeth's Medical Center, Brighton
South Shore Hospital, Weymouth
University of Massachusetts Medical School, Worcester
Dartmouth Hitchcock Medical Center, Hanover
Deborah Heart and Lung Center, Browns Mills
Englewood Hospital and Medical Center, Englewood
Rutgers New Jersey Medical School, Newark
Holy Name Medical Center, Teaneck
Stony Brook Medicine, Stony Brook
Rhode Island Hospital, Providence
The Miriam Hospital/Brown Medical School, Providence
University of Vermont Medical Center, Burlington
Vancouver General Hospital, Vancouver
St. Boniface General Hospital, Winnipeg
Queen Elizabeth II Health Science Center, Halifax
University of Western Ontario, London
The Ottawa Hospital, Ottawa
Sunnybrook Health Sciences Centre, Toronto
Toronto General Hospital, Toronto
McGill, Montreal
Jewish General Hostpital, Montreal
Chu de Quebec, Québec
Regina Qu'Appelle, Regina
St. Paul's Hospital, Saskatoon
Helsinki University Hospital, Helsinki
Lead Sponsor
Brigham and Women's Hospital
OTHER
Massachusetts General Hospital
OTHER
Boston Medical Center
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Abbott
INDUSTRY
Bard Ltd
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Cordis Corporation
INDUSTRY
Abbott Medical Devices
INDUSTRY
Canadian Society for Vascular Surgery
UNKNOWN
Eastern Vascular Society
UNKNOWN
W.L.Gore & Associates
INDUSTRY
Midwest Vascular Society
UNKNOWN
New England Society for Vascular Surgery
UNKNOWN
Society for Clinical Vascular Surgery
UNKNOWN
Society for Interventional Radiology
UNKNOWN
Southern Vascular Society
UNKNOWN
Society for Vascular Medicine
UNKNOWN
Society for Vascular Surgery
OTHER
Vascular and Endovascular Surgery Society
UNKNOWN
Vascular Interventional Advances
UNKNOWN
Western Vascular Society
UNKNOWN
Carelon Research
OTHER