Protect II, A Prospective, Multicenter Randomized Controlled Trial
NCT ID: NCT00562016
Last Updated: 2011-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
452 participants
INTERVENTIONAL
2007-10-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IMPELLA LP 2.5
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.
IABP Intra-aortic balloon pump
IABP Intra-aortic balloon pump
IABP uses counterpulsation to provide 0.2L/min coronary flow
Interventions
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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.
IABP Intra-aortic balloon pump
IABP uses counterpulsation to provide 0.2L/min coronary flow
Eligibility Criteria
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Inclusion Criteria
* 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
* Pre procedure cardiac arrest within 24 hours.
* Subject in cardiogenic shock
18 Years
90 Years
ALL
No
Sponsors
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Abiomed Inc.
INDUSTRY
Responsible Party
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Abiomed Inc
Principal Investigators
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William O'Neill
Role: PRINCIPAL_INVESTIGATOR
Not affilicated with Abiomed
Locations
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University of Alabama
Birmingham, Alabama, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
California Cardiovascular/Washington Hospital
Fremont, California, United States
Foundation for Cardiovascular Medicine
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
University of Miami
Miami, Florida, United States
Munroe Regional Medical Center
Ocala, Florida, United States
Emory Crawford Long Hospital
Atlanta, Georgia, United States
Medical College Of Georgia
Augusta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
Massach General Hospital
Boston, Massachusetts, United States
Brigham & Womens
Boston, Massachusetts, United States
St. Elizabeths Medical Center
Boston, Massachusetts, United States
Oakwood Hospital Wayne State University
Dearborn, Michigan, United States
Henry Ford Medical
Detroit, Michigan, United States
Harper Hospital
Detroit, Michigan, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
Northern Michigan
Petoskey, Michigan, United States
William Beaumont
Royal Oak, Michigan, United States
Providence Hospital and Medical Centers
Southfield, Michigan, United States
St. Louis University
St Louis, Missouri, United States
Bryan LGH Heart Institute
Lincoln, Nebraska, United States
Morristown Memorial
Morristown, New Jersey, United States
Mt. Sinai School of Medicine
New York, New York, United States
Columbia Presbyterian Hospital
New York, New York, United States
Strong Memorial Hospital
Rochester, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cardiovascular Research of Forsythe Medical
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Riverside Methodist
Columbus, Ohio, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Robert Packer Hospital
Sayre, Pennsylvania, United States
Pinnacle Health
Wormleysburg, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Veteran's Affairs Medical Center Dallas
Dallas, Texas, United States
Methodist Hospital
Houston, Texas, United States
University of Texas Medical School at Houston
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
St. Joseph's Hospital
Bellingham, Washington, United States
University of Washington
Seattle, Washington, United States
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Ottawa Heart Institute
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Royal Victoria Hospital at McGill
Montreal, Quebec, Canada
Academic Medical Center
Amsterdam, Netherlands, Netherlands
Countries
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References
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Cohen MG, Matthews R, Maini B, Dixon S, Vetrovec G, Wohns D, Palacios I, Popma J, Ohman EM, Schreiber T, O'Neill WW. Percutaneous left ventricular assist device for high-risk percutaneous coronary interventions: Real-world versus clinical trial experience. Am Heart J. 2015 Nov;170(5):872-9. doi: 10.1016/j.ahj.2015.08.009. Epub 2015 Aug 15.
Daubert MA, Massaro J, Liao L, Pershad A, Mulukutla S, Magnus Ohman E, Popma J, O'Neill WW, Douglas PS. High-risk percutaneous coronary intervention is associated with reverse left ventricular remodeling and improved outcomes in patients with coronary artery disease and reduced ejection fraction. Am Heart J. 2015 Sep;170(3):550-8. doi: 10.1016/j.ahj.2015.06.013. Epub 2015 Jun 26.
Kovacic JC, Kini A, Banerjee S, Dangas G, Massaro J, Mehran R, Popma J, O'Neill WW, Sharma SK. Patients with 3-vessel coronary artery disease and impaired ventricular function undergoing PCI with Impella 2.5 hemodynamic support have improved 90-day outcomes compared to intra-aortic balloon pump: a sub-study of the PROTECT II trial. J Interv Cardiol. 2015 Feb;28(1):32-40. doi: 10.1111/joic.12166.
Henriques JP, Ouweneel DM, Naidu SS, Palacios IF, Popma J, Ohman EM, O'Neill WW. Evaluating the learning curve in the prospective Randomized Clinical Trial of hemodynamic support with Impella 2.5 versus Intra-Aortic Balloon Pump in patients undergoing high-risk percutaneous coronary intervention: a prespecified subanalysis of the PROTECT II study. Am Heart J. 2014 Apr;167(4):472-479.e5. doi: 10.1016/j.ahj.2013.12.018. Epub 2014 Jan 3.
Dangas GD, Kini AS, Sharma SK, Henriques JP, Claessen BE, Dixon SR, Massaro JM, Palacios I, Popma JJ, Ohman M, Stone GW, O'Neill WW. Impact of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump on prognostically important clinical outcomes in patients undergoing high-risk percutaneous coronary intervention (from the PROTECT II randomized trial). Am J Cardiol. 2014 Jan 15;113(2):222-8. doi: 10.1016/j.amjcard.2013.09.008.
O'Neill WW, Kleiman NS, Moses J, Henriques JP, Dixon S, Massaro J, Palacios I, Maini B, Mulukutla S, Dzavik V, Popma J, Douglas PS, Ohman M. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study. Circulation. 2012 Oct 2;126(14):1717-27. doi: 10.1161/CIRCULATIONAHA.112.098194. Epub 2012 Aug 30.
Other Identifiers
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7182007
Identifier Type: -
Identifier Source: org_study_id
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