500 Boylston Street, Boston, MA 02116 617-419-4700
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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.
Ages:18 - 90
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
Sponsor: Abiomed Inc.
Phase: Phase 3
Trial ID: NCT00562016
Not Accepting Healthy Volunteers