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

November 19, 2007
March 18, 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 ] [ Designated as safety issue: Yes ]
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 ClinicalTrials.gov Archive Site
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 ]
Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP. [ Time Frame: In hospital events ]
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
452
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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United States,   Canada
 
NCT00562016
7182007
Yes
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