ClearWayRX System to reduce intracoronary thrombus in patients with acute coronary syndromes according to Optical Coherence Tomography after Abciximab Intracoronary Local infusion trial (COCTAIL): study rationale and design

BACKGROUND AND OBJECTIVE: Prompt reperfusion with percutaneous coronary intervention (PCI) in the setting of acute coronary syndromes (ACS) improves clinical outcomes through salvage of myocardial tissue. Although use of intracoronary glycoprotein IIb/IIIa inhibition with PCI can result in improved rates of normal epicardial flow and myocardial perfusion, several unmet needs remain. The purpose of this trial is to evaluate the efficacy and safety of an intracoronary bolus of abciximab delivered using the ClearWayRX Therapeutic Perfusion Catheter followed by a dosing regimen of intravenous abciximab infusion after PCI, compared with intracoronary abciximab infusion, via the guiding catheter, followed by a dosing regimen of intravenous abciximab infusion after PCI in patients with ACS. STUDY DESIGN: Patients with ACS (either unstable angina/non-ST-elevation myocardial infarction or ST-elevation myocardial infarction with open infarct-related artery) and visible thrombus referred for PCI will be randomized to receive one of the two treatment regimens: local intracoronary infusion of abciximab through the ClearWayRX System or intracoronary infusion of abciximab via the guiding catheter. Both groups will receive intravenous infusion of abciximab during the 12-h period following the procedure. Optical coherence tomography assessment will be performed prior to abciximab administration and after the intracoronary infusions to document the change in the thrombus score. In addition, postintervention assessments of coronary microcirculatory function will be evaluated by means of the corrected thrombolysis in myocardial infarction frame count flow and the 'myocardial blush grade'. IMPLICATIONS: If local intracoronary infusion of abciximab through the ClearWayRX System significantly reduces thrombus burden, it will lend support to the use of this delivery system as a valuable tool in patients with ACS treated with PCI.