ClearWay Rx Readmission Registry
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      The purpose of this registry is to determine if delivery of weight adjusted, in a large dose
      with either Abcixmab or Eptifibitide through the ClearWay™ RX, in patients admitted for
      primary coronary intervention lowers readmission rate. This is done 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 determine whether or not the patient
      was readmitted within 30 days, related to the index procedure.
    

Detailed description: 
      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).
    

Intervention name(s): ClearWay™ Rx catheter
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients presenting with myocardial infarction
      
Keywords: ClearWay; Glycoprotein; Primary Coronary Intervention; Abciximab; ST Elevation Myocardial Infarction; Non-ST Elevation Myocardial Infarction; Medicare; Medicaid; Registry; catheterization; readmission; Acute Coronary Syndrome; ClearwayRx Catheter