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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:
ClinicalTrials.gov Identifier:
NCT00562016
First Posted: November 21, 2007
Last Update Posted: March 21, 2011
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.
Information provided by:
Abiomed Inc.
  Purpose
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 Intervention Phase
Coronary Artery Disease Device: IMPLELLA LP 2.5 Device: IABP Intra-aortic balloon pump Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Abiomed Inc.:

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

Enrollment: 452
Study Start Date: October 2007
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


  Show 50 Study Locations
Sponsors and Collaborators
Abiomed Inc.
Investigators
Principal Investigator: William O'Neill Not affilicated with Abiomed
  More Information

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 Submitted: November 19, 2007
First Posted: November 21, 2007
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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases