ClearWay Rx Readmission Registry

The primary goal of this registry is to prospectively assess if delivery of weight adjusted, bolus only with either abcixmab or eptifibitide through the ClearWay™ RX in patients admitted for primary PCI lowers readmission rate in comparison to the historical control of the Medicare/Medicaid readmission database. The registry will record the use of the product during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.

The ClearWay™ RX Local Therapeutic Infusion Catheter is a micro-porous PTFE balloon catheter designed for the localized infusion of various diagnostic and therapeutic agents into the coronary and peripheral vasculature. The ClearWay™ RX creates a low pressure fluid layer that surrounds the balloon, allowing more effective delivery of a prescribed therapeutic agent, without excessive stress and uncontrollable mechanical disruption seen with more traditional elastomeric devices. In addition, the ClearWay™ RX is a low pressure irrigating balloon system and non-compliant balloon that limits the amount of mechanical stress on the vessel wall.

The objective of this prospective registry is to evaluate whether intracoronary (IC) delivery of Glycoprotein IIb/IIIa inhibitors (GP IIb/IIIa) during Primary Coronary Intervention (PCI) can reduce the likelihood of 30 day readmissions as a result of the original coronary intervention. Intracoronary delivery of GP IIb/IIa inhibitor Abciximab in ST Elevation Myocardial Infarction has shown to reduce myocardial infarct size, no reflow or slow flow, improve TIMI flow and Myocardial Blush Grade2,3. The ICE trial4 (N=376) compared IC delivery of GP IIb/IIa inhibitor Eptifibitide bolus only administration, bolus with maintenance infusion of Eptifibitide, to standard intravenous (IV) bolus with maintenance infusion. At 24 month follow up, the Major Adverse Coronary Events (MACE) rate was lower in the IC bolus only group (2.5%) versus IC bolus and maintenance infusion (5.8%), and IV bolus with maintenance infusion (10.8%). Further, target lesion revascularization, and readmission rates were significantly lower in the IC bolus only arm, (10.9% versus 16.8% and 28% respectively).

Inclusion criteria

• Acute Coronary Syndrome (ST elevation myocardial infarction or Non ST elevation myocardial infarction) patients requiring the use of the ClearWay™ Rx local therapeutic infusion catheter for intracoronary delivery of GP IIb/IIIa inhibitor.

Exclusion criteria

• Patients not meeting the above inclusion criterion