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

This study has been terminated.
(Futility on primary endpoint.Study confounded by statistically significant differences between the two arms re: atherectomy, duration of support.)
Sponsor:
Information provided by:
Abiomed Inc.
ClinicalTrials.gov Identifier:
NCT00562016
First received: November 19, 2007
Last updated: March 18, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
 Device: IMPLELLA LP 2.5
Device: IABP Intra-aortic balloon pump
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abiomed Inc.:

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

Secondary Outcome Measures:
  • Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP. [ Time Frame: In hospital events ] [ Designated as safety issue: Yes ]

Enrollment: 452
Study Start Date: October 2007
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562016

  Hide Study Locations
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
St. Elizabeths Medical Center
Boston, Massachusetts, United States, 02135
Brigham & Womens
Boston, Massachusetts, United States, 02115
Massach General Hospital
Boston, Massachusetts, United States, 02114
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
Mt. Sinai School of Medicine
New York, New York, United States, 10029-6574
Columbia Presbyterian Hospital
New York,, New York, United States, 10032
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
Netherlands
Academic Medical Center
Amsterdam, Netherlands
Sponsors and Collaborators
Abiomed Inc.
Investigators
Principal Investigator: William O'Neill Not affilicated with Abiomed
  More Information

No publications provided by Abiomed Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Carol Pekar/Director of Clinical and Regulatory Affairs, Abiomed Inc
ClinicalTrials.gov Identifier: NCT00562016     History of Changes
Other Study ID Numbers: 7182007
Study First Received: November 19, 2007
Last Updated: March 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abiomed Inc.:
Patient undergoing scheduled PCI

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

ClinicalTrials.gov processed this record on May 16, 2013