Acute Myocardial Infarction
Conditions
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
Brief 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).
Interventions
DEVICEClearWay™ Rx catheter
Sponsors
Cardiovascular Institute of the South Clinical Research Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30 Day Readmissions | 30 Days | Collecting data for STEMI and NSTEMI patients for 30 day readmissions after the STEMI or NSTEMI with use of the clearway catheter during the procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ST Elevation Myocardial Infarction 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 - STEMI: ST elevation myocardial infarction | 43 |
| Non ST Elevation Myocardial Infarction/ACS/UNSTABLE ANGINA 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 - NSTEMI: Non-ST elevation myocardial infarction/ACS/Unstable Angina | 16 |
| Total | 59 |
Baseline characteristics
| Characteristic | ST Elevation Myocardial Infarction | Non ST Elevation Myocardial Infarction/ACS/UNSTABLE ANGINA | Total |
|---|---|---|---|
| Age, Customized 50 to 65 years | 24 years | 8 years | 32 years |
| Age, Customized <50 years | 6 years | 1 years | 7 years |
| Age, Customized 65 to 75 years | 9 years | 6 years | 15 years |
| Age, Customized >= 75 Years | 4 years | 1 years | 5 years |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Male | 36 Participants | 13 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
30 Day Readmissions
Collecting data for STEMI and NSTEMI patients for 30 day readmissions after the STEMI or NSTEMI with use of the clearway catheter during the procedure.
Time frame: 30 Days
Population: The above documentation shows the number of readmissions within 30days of post PCI with 7 subjects. The number of cardiovascular Admissiosn within 30 days that were not preplanned or elective are 3. The number of subjects compliant with the dual anti platelet therapy consists of 59 subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No. Re-admission Within 30-days Post Pci | 30 Day Readmissions | 7 participants |
| No. of Cardiovascular Admissions Within 30-days | 30 Day Readmissions | 3 participants |
| No. of Patients Compliant With DAPT | 30 Day Readmissions | 59 participants |