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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
452
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.
IABP uses counterpulsation to provide 0.2L/min coronary flow
Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization.
Time frame: 30 days +/- 10 days
Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP.
Time frame: In hospital events
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