Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia

NACompletedINTERVENTIONAL
Enrollment

1,843

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

March 1, 2022

Study Completion Date

March 1, 2022

Conditions
Critical Limb Ischemia
Interventions
PROCEDURE

Open surgical revascularization

DEVICE

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.

Trial Locations (161)

1023

Auckland City Hospital, Grafton

3240

Waikato Hospital, Hamilton

6021

Wellington Hospital, Newtown

10029

Mount Sinai Medical Center, New York

10032

Columbia University Medical Center, New York

10305

Staten Island University Hospital, Staten Island

10467

Montefiore Medical Center, The Bronx

10595

Westchester Medical Center, Valhalla

12208

Albany Medical Center, Albany

12804

Vascular Health Partners, Queensbury

13215

SUNY Upstate Medical University, Syracuse

14215

VA Western NY Healthcare System, Buffalo

14642

University of Rochester Medical Center, Rochester

15212

Allegheny General Hospital, Pittsburgh

15232

University of Pittsburgh Medical Center, Pittsburgh

17033

Penn State Milton S. Hershey Medical Center, Hershey

17043

Pinnacle Health System, Wormleysburg

19140

Temple University, Philadelphia

20010

Medstar Washington Hospital Center, Washington D.C.

20037

GW Medical Faculty Associates, Inc., Washington D.C.

21201

University of Maryland Medical System, Baltimore

21210

Johns Hopkins Hospital, Baltimore

Loyola University Medical Center, Baltimore

21218

MedStar Union Memorial Hospital, Baltimore

22042

Inova Fairfax Hospital, Falls Church

22908

University of Virginia, Charlottesville

23507

Sentara Vascular Specialists, Norfolk

25304

CAMC Clinical Trials Center, Charleston

27157

Wake Forest Baptist Medical Center, Winston-Salem

27599

University of North Carolina, Chapel Hill

27607

North Carolina Heart and Vascular Research, Raleigh

27705

Duke University, Durham

Durham VAMC, Durham

29425

Medical University of South Carolina, Charleston

29605

Prisma Health-Upstate (Formerly Greenville Memorial Hospital), Greenville

30033

Atlanta VA Medical Center, Decatur

30303

Emory University, Atlanta

32610

University of Florida (Gainesville), Gainesville

33140

Mount Sinai Miami, Miami Springs

33176

Baptist Hospital of Miami, Miami

33606

Tampa General Hospital, Tampa

33612

Tampa VAMC, Tampa

34471

Florida Hospital Ocala, Ocala

35294

The University of Alabama at Birmingham, Birmingham

37660

Wellmont Holston Valley Medical Center, Kingsport

37920

University of Tennessee Medical Center, Knoxville

43210

The Ohio State University, Columbus

43214

Ohio Health Research Institute, Columbus

43615

University of Toledo Medical Center, Toledo

44106

University Hospitals of Cleveland/Case Western Reserve University, Cleveland

44109

Cleveland Clinic Foundation, Cleveland

46202

Indiana University Medical School, Indianapolis

48073

William Beaumont Hospital, Royal Oak

48105

VA Ann Arbor Healthcare System, Ann Arbor

48106

Michigan Heart/St. Joseph Mercy Ann Arbor Hospital, Ann Arbor

48109

University of Michigan Health System, Ann Arbor

48202

Henry Ford Health System, Detroit

48507

Michigan Vascular Center, Flint

49503

Spectrum Health, Grand Rapids

50124

San Giovanni di Dio Hospital, Florence

50266

Mercy Hospital Medical Center, West Des Moines

53226

Medical College of Wisconsin, Milwaukee

53295

Milwaukee VAMC, Milwaukee

53706

University of Wisconsin-Madison, Madison

53713

Meriter Wisconsin Heart, Madison

54601

Gundersen Health System, La Crosse

55407

Minneapolis Heart Hospital/Abbott Northwestern Hosp., Minneapolis

55417

Minneapolis VAMC, Minneapolis

55901

Mayo Clinic, Rochester

57108

North Central Heart Institute, Sioux Falls

60153

Loyola University Medical Center, Maywood

60190

Central DuPage Hospital (Cadence), Chicago

60612

Rush University Medical Center, Chicago

60637

University of Chicago Medicine, Chicago

62526

Decatur Memorial Hospital, Decatur

62702

Southern Illinois University School of Medicine, Springfield

63106

St. Louis VA Medical Center, St Louis

64116

Midwest Aortic Vascular Institute, Kansas City

65212

University of Missouri, Columbia

68198

University of Nebraska Medical Center, Omaha

70121

Ochsner Medical Center, New Orleans

71130

University Health System: LSU Health Sciences, Shreveport

72205

University of Arkansas for Medical Services, Little Rock

73104

University of Oklahoma Health Sciences Center, Oklahoma City

74135

University of Oklahoma College of Medicine at Tulsa, Tulsa

75390

Dallas VA Medical Center, Dallas

76508

Scott and White - Temple, Temple

77030

Memorial Hermann Hospital TMC, Houston

Michael E. DeBakey VA Medical Center, Houston

80024

Denver Health, Denver

80045

University of Colorado Hospital, Aurora

80218

Vascular Institute of the Rockies, Denver

80220

Rocky Mountain Regional VA, Denver

84132

The University of Utah, Salt Lake City

85016

Arizona Heart Hospital, Phoenix

85719

University of Arizona - Banner University Medical Center, Tucson

85745

Carondelet Heart & Vascular Institute, Tucson

87102

New Mexico Heart Institute, Albuquerque

87108

New Mexico VA Medical Center, Albuquerque

90027

Kaiser Permanente Los Angeles Medical Center, Los Angeles

90073

VA Greater Los Angeles, Los Angeles

90089

Keck Medical Center of USC, Los Angeles

90095

UCLA-Gonda Vascular Surgery, Los Angeles

90509

Harbor - UCLA Medical Center, Torrance

90822

VA Long Beach Healthcare System, Long Beach

92037

San Diego VAMC, La Jolla

UC San Diego Sulpizio Cardiovascular Center, La Jolla

92123

Kaiser Permanente (San Diego), San Diego

92354

Loma Linda University Medical Center, Loma Linda

92357

Loma Linda VA Medical Center, Loma Linda

92697

University of California - Irvine, Irvine

94118

Kaiser Permanente Northern California, San Francisco

94121

San Francisco Veterans Affairs Medical Center, San Francisco

94143

University of California-San Francisco Medical Center, San Francisco

94304

VA Palo Alto Health Care, Palo Alto

94305

Stanford Hospital, Stanford

95655

Sacramento VA Medical Center, Sacramento

95817

University of California Davis Medical Center, Sacramento

96819

Kaiser Foundation Hospital, Honolulu

97213

Providence Heart and Vascular Institute, Portland

97239

Oregon Health and Science University, Portland

Portland VA Medical Center, Portland

98101

Benaroya Research Institute at Virginia Mason, Seattle

98104

Harborview Medical Center, Seattle

98122

Swedish Medical Center, Seattle

99204

Providence Sacred Heart Medical Center, Spokane

601611

Northwestern Memorial Hospital, Winfield

06105

St. Francis Hospital and Medical Center, Hartford

06510

Yale-New Haven Hospital, New Haven

06516

West Haven VAMC, West Haven

04102

Maine Medical Center, Portland

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

02118

Boston Medical Center, Boston

02132

VA Boston Healthcare System, Boston

02215

Beth Israel Deaconess Medical Center, Boston

02135

Steward St. Elizabeth's Medical Center, Brighton

02189

South Shore Hospital, Weymouth

01655

University of Massachusetts Medical School, Worcester

03756

Dartmouth Hitchcock Medical Center, Hanover

08015

Deborah Heart and Lung Center, Browns Mills

07631

Englewood Hospital and Medical Center, Englewood

07103

Rutgers New Jersey Medical School, Newark

07666

Holy Name Medical Center, Teaneck

11794-8191

Stony Brook Medicine, Stony Brook

02905

Rhode Island Hospital, Providence

02906

The Miriam Hospital/Brown Medical School, Providence

05401

University of Vermont Medical Center, Burlington

V5Z1M9

Vancouver General Hospital, Vancouver

R2H 2A6

St. Boniface General Hospital, Winnipeg

B3H3A7

Queen Elizabeth II Health Science Center, Halifax

N6A5W9

University of Western Ontario, London

K1Y4E9

The Ottawa Hospital, Ottawa

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 2C4

Toronto General Hospital, Toronto

H3A1A1

McGill, Montreal

H3T 1E2

Jewish General Hostpital, Montreal

G1L 3L5

Chu de Quebec, Québec

S4P 0W5

Regina Qu'Appelle, Regina

S7M0Z9

St. Paul's Hospital, Saskatoon

F100029

Helsinki University Hospital, Helsinki

All Listed Sponsors
collaborator

Brigham and Women's Hospital

OTHER

collaborator

Massachusetts General Hospital

OTHER

collaborator

Boston Medical Center

OTHER

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Abbott

INDUSTRY

collaborator

Bard Ltd

INDUSTRY

collaborator

Boston Scientific Corporation

INDUSTRY

collaborator

Cordis Corporation

INDUSTRY

collaborator

Abbott Medical Devices

INDUSTRY

collaborator

Canadian Society for Vascular Surgery

UNKNOWN

collaborator

Eastern Vascular Society

UNKNOWN

collaborator

W.L.Gore & Associates

INDUSTRY

collaborator

Midwest Vascular Society

UNKNOWN

collaborator

New England Society for Vascular Surgery

UNKNOWN

collaborator

Society for Clinical Vascular Surgery

UNKNOWN

collaborator

Society for Interventional Radiology

UNKNOWN

collaborator

Southern Vascular Society

UNKNOWN

collaborator

Society for Vascular Medicine

UNKNOWN

collaborator

Society for Vascular Surgery

OTHER

collaborator

Vascular and Endovascular Surgery Society

UNKNOWN

collaborator

Vascular Interventional Advances

UNKNOWN

collaborator

Western Vascular Society

UNKNOWN

lead

Carelon Research

OTHER