INFUSE-AMI is a multicenter, open-label, controlled, single-blind randomized study enrolling 452 subjects with anterior
STEMI and an occluded proximal or mid-left anterior descending artery with
thrombosis in
myocardial infarction 0, 1, or 2 grade flow undergoing primary PCI with
bivalirudin anticoagulation. Subjects are randomized in a 2 × 2 factorial to one of the following 4 arms: (1) local infusion of
abciximab using the ClearWay RX Local Therapeutic Infusion
Catheter (ClearWay, Atrium Medical Corp, Hudson, NH) after aspiration with a 6F Export Aspiration
Catheter (Medtronic, Inc, Minneapolis, MN), (2) local infusion of
abciximab using the ClearWay RX Infusion
Catheter and no aspiration, (3) no local infusion of
abciximab and aspiration with a 6F Export Aspiration
Catheter, or (4) no local infusion of
abciximab and no aspiration. The primary end point is
infarct size (percentage of total left ventricular mass) at 30 days measured by cardiac magnetic resonance imaging. Other secondary end points include microvascular obstruction by cardiac magnetic resonance imaging at 5 days, ST-segment resolution, angiographic myocardial perfusion,
thrombus burden, angiographic complications, and clinical events through 1-year follow-up. Safety end points include major and minor
bleeding.
SUMMARY: