ClearWay Rx Readmission Registry
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 12/1/2018 |
| Start Date: | September 2011 |
| End Date: | April 2014 |
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.
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.
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).
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
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