IntraCoronary Abciximab with the ClearWay Catheter To Improve Outcomes with Lysis (IC ClearLy) Trial

INTERVENTION: Trade Name: REOPRO*EV 1F 5ML 10MG/5ML Pharmaceutical Form: Solution for injection INN or Proposed INN: Abciximab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2‐ Trade Name: REOPRO*EV 1F 5ML 10MG/5ML Pharmaceutical Form: Solution for injection INN or Proposed INN: Abciximab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2‐ CONDITION: The study will enroll male or female ACS patients at least 18 years of age presenting with STEMI with angiographically visible thrombus (Thrombus Grade >2) who are planned to undergo emergency PCI during the acute phase of the event. ; MedDRA version: 9.1 Level: LLT Classification code 10037690 PRIMARY OUTCOME: Main Objective: The primary objective of the study is to demonstrate that an IntraCoronary bolus of abciximab delivered with the ClearWay RX catheter added to a post‐PCI intravenous infusion regimen of abciximab will result in significant additional clot resolution in vivo when compared with an intravenous bolus of abciximab when added to a post PCI intravenous infusion regimen of abciximab. The primary endpoint chosen to evaluate this hypothesis is infarct size as assessed on CMR. It is hypothesized that infarct size in the IC infusion group will be significantly reduced as compared with the IV infusion control arm. Primary end point(s): Reduction in infarct size for the IC infusion group compared to the control as measured with cardiac MRI imaging. Secondary Objective: The median post‐PCI corrected TIMI frame count (cTFC) The frequency of post PCI TIMI Grade 2/3 flow and post PCI TIMI grade 3 flow The frequency of post PCI TIMI Myocardial Perfusion Grade 3 and TIMI Myocardial Perfusion Grade 2/3ST segment resolution at 90 minutes following PCIPeak post PCI CK‐MB and Troponin I levels. The frequency of sidebranch occlusion post PIC The frequency of distal cutoff/embolization post PCI The frequency of death / MI at 30 days, and the frequency of each component separately The frequency of q waves on the discharge EKG The improvement in in percent diameter stenosis before and after ClearWay deployment prior to intracoronary stent placement The above endpoints will be first analyzed among all patients, and separately for those patients in whom clot aspiration was performed prior to deployment and in those in whom aspiration was not performed prior to depolyment INCLUSION CRITERIA: 1. Patients (men or women) at least 18 years of age 2. STEMI: Presenting with ischemic chest discomfort >20 minutes and <6 hours of duration suggestive of acute myocardial infarction AND ST elevation > 1mm (>0.1mV) in two contiguous limb leads OR >2mm (>0.2mV) in two contiguous precordial leads 3. Must have signed the informed consent form prior to performance of study‐related procedures 4. Native dominant and proximal culprit vessel ?2.5 mm in diameter 5. Angiographically identifiable thrombus (presence of a filling defect within the coronary lumen surrounded by contrast medium observed in multiple projections, without calcium within the filling defect, or persistence of contrast medium within the coronary lumen) 6. Pre‐PCI Thrombus score (TS) ≥2 (angiographically apparent thrombus that is > ? the vessel diameter) 7. Pre‐PCI TIMI flow grade of 0‐2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults