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Protect II, A Prospective, Multicenter Randomized Controlled Trial (PROTECT II)

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ClinicalTrials.gov 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.

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: IMPLELLA LP 2.5 Device: IABP Intra-aortic balloon pump Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2007
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: IMPELLA LP 2.5 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.
Active Comparator: IABP Intra-aortic balloon pump Device: IABP Intra-aortic balloon pump
IABP uses counterpulsation to provide 0.2L/min coronary flow

Primary Outcome Measures :
  1. Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization. [ Time Frame: 30 days +/- 10 days ]

Secondary Outcome Measures :
  1. Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP. [ Time Frame: In hospital events ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562016

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Sponsors and Collaborators
Abiomed Inc.
Principal Investigator: William O'Neill Not affilicated with Abiomed

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Carol Pekar/Director of Clinical and Regulatory Affairs, Abiomed Inc
ClinicalTrials.gov Identifier: NCT00562016     History of Changes
Other Study ID Numbers: 7182007
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: March 21, 2011
Last Verified: March 2011

Keywords provided by Abiomed Inc.:
Patient undergoing scheduled PCI

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases