To determine the best way to treat patients with an acute anterior wall myocardial infarction with ST segment elevation
Atrium has reported that its ClearWay RX Local Therapeutic Infusion catheter, which is being utilised 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.
ClearWay RX Local Therapeutic Infusion catheter is a thin, microporous PTFE balloon mounted on a .014” rapid exchange catheter. It allows for a super selective infusion of a prescribed amount of drug into a localised targeted area.
The balloon controllably engages the vessel wall to gently and automatically occlude blood flow during infusion thus providing up to 500 times the systemic concentration at the local site of delivery. ClearWay RX maximises drug availability, concentration, and residence time to enhance the desired therapeutic, said the company.
Atrium Medical has enrolled first patient in the Infuse AMI trial. Infuse AMI is a multi-center, multi-national, prospective, randomised, 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.
In the study, the company expects to enroll 452 patients at up to 40 sites in the US 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.
The endpoints of the study 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.