Study Stopped
Futility on primary endpoint.Study confounded by statistically significant differences between the two arms re: atherectomy, duration of support.
Protect II, A Prospective, Multicenter Randomized Controlled Trial
PROTECT II
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
1 other identifier
interventional
452
3 countries
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 coronary-artery-disease
Started Oct 2007
Typical duration for phase_3 coronary-artery-disease
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 19, 2007
CompletedFirst Posted
Study publicly available on registry
November 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedMarch 21, 2011
March 1, 2011
3.5 years
November 19, 2007
March 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization.
30 days +/- 10 days
Secondary Outcomes (1)
Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP.
In hospital events
Study Arms (2)
IMPELLA LP 2.5
EXPERIMENTALIABP Intra-aortic balloon pump
ACTIVE COMPARATORInterventions
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 uses counterpulsation to provide 0.2L/min coronary flow
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- ST elevation M.I.
- Pre procedure cardiac arrest within 24 hours.
- Subject in cardiogenic shock
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abiomed Inc.lead
Study Sites (50)
University of Alabama
Birmingham, Alabama, 35294, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006, United States
California Cardiovascular/Washington Hospital
Fremont, California, 94538, United States
Foundation for Cardiovascular Medicine
La Jolla, California, 92037, United States
University of Southern California
Los Angeles, California, 90033, United States
University of Miami
Miami, Florida, 33136, United States
Munroe Regional Medical Center
Ocala, Florida, 34471, United States
Emory Crawford Long Hospital
Atlanta, Georgia, 30308, United States
Medical College Of Georgia
Augusta, Georgia, 30912, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912, United States
Massach General Hospital
Boston, Massachusetts, 02114, United States
Brigham & Womens
Boston, Massachusetts, 02115, United States
St. Elizabeths Medical Center
Boston, Massachusetts, 02135, United States
Oakwood Hospital Wayne State University
Dearborn, Michigan, 48124, United States
Henry Ford Medical
Detroit, Michigan, 35294, United States
Harper Hospital
Detroit, Michigan, 48201, United States
St. John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Northern Michigan
Petoskey, Michigan, 49770, United States
William Beaumont
Royal Oak, Michigan, 48073, United States
Providence Hospital and Medical Centers
Southfield, Michigan, 48075, United States
St. Louis University
St Louis, Missouri, 63110, United States
Bryan LGH Heart Institute
Lincoln, Nebraska, 68506, United States
Morristown Memorial
Morristown, New Jersey, 07962, United States
Mt. Sinai School of Medicine
New York, New York, 10029-6574, United States
Columbia Presbyterian Hospital
New York, New York, 10032, United States
Strong Memorial Hospital
Rochester, New York, 14642, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cardiovascular Research of Forsythe Medical
Winston-Salem, North Carolina, 27103, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Riverside Methodist
Columbus, Ohio, 43214, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
Pinnacle Health
Wormleysburg, Pennsylvania, 17043, United States
York Hospital
York, Pennsylvania, 17403, United States
Veteran's Affairs Medical Center Dallas
Dallas, Texas, 75216, United States
Methodist Hospital
Houston, Texas, 77030, United States
University of Texas Medical School at Houston
Houston, Texas, 77030, United States
Intermountain Medical Center
Murray, Utah, 84157, United States
St. Joseph's Hospital
Bellingham, Washington, 98225, United States
University of Washington
Seattle, Washington, 98198, United States
Royal Alexandra Hospital
Edmonton, Alberta, T5H3V9, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G2B7, Canada
Ottawa Heart Institute
Ottawa, Ontario, K1Y4W7, Canada
Toronto General Hospital
Toronto, Ontario, M5G1Z5, Canada
Royal Victoria Hospital at McGill
Montreal, Quebec, H3A1A1, Canada
Academic Medical Center
Amsterdam, Netherlands, Netherlands
Related Publications (6)
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.
PMID: 26542494DERIVEDDaubert 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.
PMID: 26385039DERIVEDKovacic 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.
PMID: 25689546DERIVEDHenriques 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.
PMID: 24655695DERIVEDDangas 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.
PMID: 24527505DERIVEDO'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.
PMID: 22935569DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William O'Neill
Not affilicated with Abiomed
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 19, 2007
First Posted
November 21, 2007
Study Start
October 1, 2007
Primary Completion
April 1, 2011
Study Completion
September 1, 2011
Last Updated
March 21, 2011
Record last verified: 2011-03