ClearWay Rx Readmission Registry
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||ClearWay Rx Readmission Registry|
- 30 day readmissions [ Time Frame: 30 Days ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
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.
|Device: ClearWay™ Rx catheter|
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 STEMI 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673893
|Contact: Shontel Cleveland, LPNemail@example.com|
|Contact: Nick Cavros, MDfirstname.lastname@example.org|
|United States, Louisiana|
|Cardiovascular Institute of the South Clinical Research Corporation||Recruiting|
|Lafayette, Louisiana, United States, 70503|
|Contact: Shontel Cleveland, LPN 337-291-6961 email@example.com|
|Contact: Nick Cavros, MD 337-289-8429 firstname.lastname@example.org|
|Principal Investigator: Nick Cavros, MD|
|Principal Investigator:||Nick Cavros, MD||Cardiovascular Institute of the South|