Clinical trial NCT00562016: Protect II, A Prospective, Multicenter Randomized Controlled Trial
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Patient undergoing scheduled PCI
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2007-11-21
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization.
timeFrame: 30 days +/- 10 days
Secondary outcomes:
measure: Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP.
timeFrame: In hospital events
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Gilbert
country: United States
facility: Mercy Gilbert Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Banner Good Samaritan Medical Center
state: Arizona
city: Fremont
country: United States
facility: California Cardiovascular/Washington Hospital
state: California
city: La Jolla
country: United States
facility: Foundation for Cardiovascular Medicine
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Atlanta
country: United States
facility: Emory Crawford Long Hospital
state: Georgia
city: Augusta
country: United States
facility: Medical College Of Georgia
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Boston
country: United States
facility: Massach General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Womens
state: Massachusetts
city: Boston
country: United States
facility: St. Elizabeths Medical Center
state: Massachusetts
city: Dearborn
country: United States
facility: Oakwood Hospital Wayne State University
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical
state: Michigan
city: Detroit
country: United States
facility: Harper Hospital
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital and Medical Centers
state: Michigan
city: St. Louis
country: United States
facility: St. Louis University
state: Missouri
city: Lincoln
country: United States
facility: Bryan LGH Heart Institute
state: Nebraska
city: Morristown
country: United States
facility: Morristown Memorial
state: New Jersey
city: New York,
country: United States
facility: Columbia Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Mt. Sinai School of Medicine
state: New York
city: Rochester
country: United States
facility: Strong Memorial Hospital
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Cardiovascular Research of Forsythe Medical
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Veteran's Affairs Medical Center Dallas
state: Texas
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas Medical School at Houston
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Bellingham
country: United States
facility: St. Joseph's Hospital
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Royal Victoria Hospital at McGill
state: Quebec
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
affiliation: Not affilicated with Abiomed
name: William O'Neill
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.