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Clinical Trials/NCT00562016
NCT00562016
Terminated
Phase 3

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

Abiomed Inc.50 sites in 3 countries452 target enrollmentOctober 2007
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ConditionsCoronary Artery Disease

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Abiomed Inc.
Enrollment
452
Locations
50
Primary Endpoint
Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization.
Status
Terminated
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2007
End Date
September 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization.

Time Frame: 30 days +/- 10 days

Secondary Outcomes

  • Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP.(In hospital events)

Study Sites (50)

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