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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:
Information provided by:
Abiomed Inc.
ClinicalTrials.gov Identifier:
NCT00562016
First received: November 19, 2007
Last updated: March 18, 2011
Last verified: March 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562016

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

No publications provided by Abiomed Inc.

Additional 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
Study First Received: November 19, 2007
Last Updated: March 18, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013