Protect II, A Prospective, Multicenter Randomized Controlled Trial

PHASE3TerminatedINTERVENTIONAL
Enrollment

452

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

April 30, 2011

Study Completion Date

September 30, 2011

Conditions
Coronary Artery Disease
Interventions
DEVICE

IMPLELLA LP 2.5

Insertion of the LP 2.5 IMPELLA circulatory support system that can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta at 2.5 L/min.

DEVICE

IABP Intra-aortic balloon pump

IABP uses counterpulsation to provide 0.2L/min coronary flow

Trial Locations (50)

10032

Columbia Presbyterian Hospital, New York

14642

Strong Memorial Hospital, Rochester

15213

UPMC Presbyterian Hospital, Pittsburgh

17043

Pinnacle Health, Wormleysburg

17403

York Hospital, York

18840

Robert Packer Hospital, Sayre

20912

Washington Adventist Hospital, Takoma Park

27103

Cardiovascular Research of Forsythe Medical, Winston-Salem

27710

Duke University Medical Center, Durham

28203

Carolinas Medical Center, Charlotte

30308

Emory Crawford Long Hospital, Atlanta

30912

Medical College Of Georgia, Augusta

33136

University of Miami, Miami

34471

Munroe Regional Medical Center, Ocala

35294

University of Alabama, Birmingham

Henry Ford Medical, Detroit

43214

Riverside Methodist, Columbus

45267

University of Cincinnati, Cincinnati

48073

William Beaumont, Royal Oak

48075

Providence Hospital and Medical Centers, Southfield

48124

Oakwood Hospital Wayne State University, Dearborn

48201

Harper Hospital, Detroit

48236

St. John Hospital and Medical Center, Detroit

49770

Northern Michigan, Petoskey

60153

Loyola University Medical Center, Maywood

60637

University of Chicago Medical Center, Chicago

63110

St. Louis University, St Louis

68506

Bryan LGH Heart Institute, Lincoln

75216

Veteran's Affairs Medical Center Dallas, Dallas

77030

Methodist Hospital, Houston

University of Texas Medical School at Houston, Houston

84157

Intermountain Medical Center, Murray

85006

Banner Good Samaritan Medical Center, Phoenix

85297

Mercy Gilbert Medical Center, Gilbert

90033

University of Southern California, Los Angeles

92037

Foundation for Cardiovascular Medicine, La Jolla

94538

California Cardiovascular/Washington Hospital, Fremont

98198

University of Washington, Seattle

98225

St. Joseph's Hospital, Bellingham

02114

Massach General Hospital, Boston

02115

Brigham & Womens, Boston

02135

St. Elizabeths Medical Center, Boston

07962

Morristown Memorial, Morristown

10029-6574

Mt. Sinai School of Medicine, New York

T5H3V9

Royal Alexandra Hospital, Edmonton

T6G2B7

University of Alberta Hospital, Edmonton

K1Y4W7

Ottawa Heart Institute, Ottawa

M5G1Z5

Toronto General Hospital, Toronto

H3A1A1

Royal Victoria Hospital at McGill, Montreal

Unknown

Academic Medical Center, Amsterdam

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Abiomed Inc.

INDUSTRY