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ClearWay Rx Readmission Registry

C

Cardiovascular Institute of the South Clinical Research Corporation

Status

Completed

Conditions

Acute Myocardial Infarction

Treatments

Device: ClearWay™ Rx catheter

Study type

Observational

Funder types

Other

Identifiers

NCT01673893
K061680

Details and patient eligibility

About

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.

Full 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).

Enrollment

59 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

59 participants in 2 patient groups

ST elevation myocardial infarction
Description:
The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure. 1st Group/Cohort - ST elevation myocardial infarction
Treatment:
Device: ClearWay™ Rx catheter
Non-ST elevation myocardial infarction/ACS/UNSTABLE ANGINA
Description:
The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure. 2nd Group/Cohort - Non-ST elevation myocardial infarction/ACS/Unstable Angina
Treatment:
Device: ClearWay™ Rx catheter

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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