Protect II, A Prospective, Multicenter Randomized Controlled Trial (PROTECT II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00562016
Recruitment Status : Terminated (Futility on primary endpoint.Study confounded by statistically significant differences between the two arms re: atherectomy, duration of support.)
First Posted : November 21, 2007
Last Update Posted : March 21, 2011
Information provided by:
Abiomed Inc.

Brief Summary:
The IMPELLA® 2.5 System will be superior to Intra Aortic Balloon Pump in preventing the composite rate of major adverse events during and after the PCI procedure.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: IMPLELLA LP 2.5 Device: IABP Intra-aortic balloon pump Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PROTECT II: A Prospective, Multi-center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP)in Patients Undergoing Non Emergent High Risk PCI
Study Start Date : October 2007
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: IMPELLA LP 2.5 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.
Active Comparator: IABP Intra-aortic balloon pump Device: IABP Intra-aortic balloon pump
IABP uses counterpulsation to provide 0.2L/min coronary flow

Primary Outcome Measures :
  1. Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization. [ Time Frame: 30 days +/- 10 days ]

Secondary Outcome Measures :
  1. Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP. [ Time Frame: In hospital events ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Informed consent
  • Subject is indicated for a NON emergent percutaneous treatment of at least on de novo or restenotic lesion in a native coronary vessel or bypass graft.
  • Patient presents with:

    • A compromised Ejection Fraction
    • Intervention on the last patent coronary conduit
    • Intervention on an unprotected left main artery or
    • Patient presenting with triple vessel disease.

Exclusion Criteria:

  • ST elevation M.I.
  • Pre procedure cardiac arrest within 24 hours.
  • Subject in cardiogenic shock

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00562016

  Hide Study Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Arizona
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
United States, California
California Cardiovascular/Washington Hospital
Fremont, California, United States, 94538
Foundation for Cardiovascular Medicine
La Jolla, California, United States, 92037
University of Southern California
Los Angeles, California, United States, 90033
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Munroe Regional Medical Center
Ocala, Florida, United States, 34471
United States, Georgia
Emory Crawford Long Hospital
Atlanta, Georgia, United States, 30308
Medical College Of Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Maryland
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
United States, Massachusetts
Massach General Hospital
Boston, Massachusetts, United States, 02114
Brigham & Womens
Boston, Massachusetts, United States, 02115
St. Elizabeths Medical Center
Boston, Massachusetts, United States, 02135
United States, Michigan
Oakwood Hospital Wayne State University
Dearborn, Michigan, United States, 48124
Henry Ford Medical
Detroit, Michigan, United States, 35294
Harper Hospital
Detroit, Michigan, United States, 48201
St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Northern Michigan
Petoskey, Michigan, United States, 49770
William Beaumont
Royal Oak, Michigan, United States, 48073
Providence Hospital and Medical Centers
Southfield, Michigan, United States, 48075
United States, Missouri
St. Louis University
St. Louis, Missouri, United States, 63110
United States, Nebraska
Bryan LGH Heart Institute
Lincoln, Nebraska, United States, 68506
United States, New Jersey
Morristown Memorial
Morristown, New Jersey, United States, 07962
United States, New York
Columbia Presbyterian Hospital
New York,, New York, United States, 10032
Mt. Sinai School of Medicine
New York, New York, United States, 10029-6574
Strong Memorial Hospital
Rochester, New York, United States, 14642
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 27710
Cardiovascular Research of Forsythe Medical
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Riverside Methodist
Columbus, Ohio, United States, 43214
United States, Pennsylvania
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
Pinnacle Health
Wormleysburg, Pennsylvania, United States, 17043
York Hospital
York, Pennsylvania, United States, 17403
United States, Texas
Veteran's Affairs Medical Center Dallas
Dallas, Texas, United States, 75216
Methodist Hospital
Houston, Texas, United States, 77030
University of Texas Medical School at Houston
Houston, Texas, United States, 77030
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
United States, Washington
St. Joseph's Hospital
Bellingham, Washington, United States, 98225
University of Washington
Seattle, Washington, United States, 98198
Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H3V9
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G2B7
Canada, Ontario
Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y4W7
Toronto General Hospital
Toronto, Ontario, Canada, M5G1Z5
Canada, Quebec
Royal Victoria Hospital at McGill
Montreal, Quebec, Canada, H3A1A1
Academic Medical Center
Amsterdam, Netherlands
Sponsors and Collaborators
Abiomed Inc.
Principal Investigator: William O'Neill Not affilicated with Abiomed

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Carol Pekar/Director of Clinical and Regulatory Affairs, Abiomed Inc Identifier: NCT00562016     History of Changes
Other Study ID Numbers: 7182007
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: March 21, 2011
Last Verified: March 2011

Keywords provided by Abiomed Inc.:
Patient undergoing scheduled PCI

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases