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.

November 19, 2007
November 21, 2007
March 21, 2011
October 2007
April 2011   (Final data collection date for primary outcome measure)
Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization. [ Time Frame: 30 days +/- 10 days ]
Composite rate of intra porcedural and post procedural major events. Death, MI,Stroke,TIA, TVR, CABG, Acute renal failure, severe hypotension, CPR Vent Arrythmia requiring, failure angiographic success. [ Time Frame: 30 days ]
Complete list of historical versions of study NCT00562016 on Archive Site
Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP. [ Time Frame: In hospital events ]
Same as current
Not Provided
Not Provided
Protect II, A Prospective, Multicenter Randomized Controlled Trial
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
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Artery Disease
  • 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.
  • Device: IABP Intra-aortic balloon pump
    IABP uses counterpulsation to provide 0.2L/min coronary flow
  • Experimental: IMPELLA LP 2.5
    Intervention: Device: IMPLELLA LP 2.5
  • Active Comparator: IABP Intra-aortic balloon pump
    Intervention: Device: IABP Intra-aortic balloon pump

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2011
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   Netherlands,   United States
Not Provided
Not Provided
Carol Pekar/Director of Clinical and Regulatory Affairs, Abiomed Inc
Abiomed Inc.
Not Provided
Principal Investigator: William O'Neill Not affilicated with Abiomed
Abiomed Inc.
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP