Dec 7 2009
Atrium
Medical Corporation announced that the 1st patient was enrolled in the
INFUSE AMI trial. INFUSE AMI is a multi-center, multi-national,
prospective, randomized, single blind trial examining how patients with
heart attacks are treated. The study's aim is to help determine the best
way to treat patients with an acute anterior wall myocardial infarction
(acute MI) with ST segment elevation, commonly referred to as STEMIs.
INFUSE AMI will enroll 452 patients at up to 40 sites in the U.S. and
Europe in a 2 by 2 factorial design (4 study arms). The study will assess
4 different ways to treat the blood clot (thrombus) causing the heart
attack. These include: Intracoronary (IC) infusion of abciximab* via Atrium's ClearWay™ RX Local
Therapeutic Infusion catheter, thrombus aspiration, thrombus aspiration
followed by IC infusion of abciximab* with ClearWay™ RX, and the current
standard of care which is traditional percutaneous coronary intervention
(PCI), often with a stent. This study will help to identify which of these
four study arms can provide better patient outcomes with the goal of
reducing the infarct size (heart muscle damage) during a heart attack and
restoring flow in the infarct related artery and microvasculature in the
heart muscle. The study's endpoints will include measuring infarct size at
30 days using a powerful new imaging technique called cardiac MRI,
microvascular obstruction, ST segment resolution, myocardial perfusion,
impact on thrombus burden, and outcomes on bleeding.
Atrium's novel ClearWay™ RX
Local Therapeutic Infusion catheter, which is being utilized in two arms of
the trial, provides super selective, local intracoronary infusion of
medication, allowing more medication to act locally at a higher
concentration and for a longer period of time to enhance its therapeutic
effect on the occluding blood clot and diseased artery.
SOURCE: Atrium Medical Corporation