N/A
N=59
ClearWay Rx Readmission Registry
Acute Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT01673893 ↗Enrolled (actual)
59
Serious AEs
—
Results posted
Sep 2018
Primary outcome: Primary: 30 Day Readmissions — 7; 3; 59 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- ClearWay™ Rx catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cardiovascular Institute of the South Clinical Research Corporation
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 30 Day Readmissions |
7; 3; 59 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01673893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.