ClearWay Rx Readmission Registry

Acute Myocardial Infarction Clinical Trial

— ClearWay  

Official title:

ClearWay Rx Readmission Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673893
• Other study ID #: K061680
• Status: Completed
• Start date: September 2011
• Est. completion date: April 2014

Study information

• Verified date: November 2018
• Source: Cardiovascular Institute of the South Clinical Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• ClearWay™ Rx catheter

Locations

Country	Name	City	State
United States	Cardiovascular Institute of the South Clinical Research Corporation	Lafayette	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Cardiovascular Institute of the South Clinical Research Corporation

Country where clinical trial is conducted

United States, 

References & Publications (5)

Curtis JP, Schreiner G, Wang Y, Chen J, Spertus JA, Rumsfeld JS, Brindis RG, Krumholz HM. All-cause readmission and repeat revascularization after percutaneous coronary intervention in a cohort of medicare patients. J Am Coll Cardiol. 2009 Sep 1;54(10):903-7. doi: 10.1016/j.jacc.2009.04.076. — View Citation

Hassan W, Al-Sergani H, Al Buraiki J, Dunn B, Al Turki F, Akhras N, Elshaer F, Nawaz M, Kharabsheh S, ElKum N. Immediate and intermediate results of intracoronary stand-alone bolus administration of eptifibatide during coronary intervention (ICE) study. Am Heart J. 2007 Aug;154(2):345-51. — View Citation

Krumholz HM, Merrill AR, Schone EM, Schreiner GC, Chen J, Bradley EH, Wang Y, Wang Y, Lin Z, Straube BM, Rapp MT, Normand SL, Drye EE. Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmission. Circ Cardiovasc Qual Outcomes. 2009 Sep;2(5):407-13. doi: 10.1161/CIRCOUTCOMES.109.883256. Epub 2009 Jul 9. — View Citation

Romagnoli E, Burzotta F, Trani C, Biondi-Zoccai GG, Giannico F, Crea F. Rationale for intracoronary administration of abciximab. J Thromb Thrombolysis. 2007 Feb;23(1):57-63. Review. — View Citation

Thiele H, Schindler K, Friedenberger J, Eitel I, Fürnau G, Grebe E, Erbs S, Linke A, Möbius-Winkler S, Kivelitz D, Schuler G. Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the randomized Leipzig immediate percutaneous coronary intervention abciximab IV versus IC in ST-elevation myocardial infarction trial. Circulation. 2008 Jul 1;118(1):49-57. doi: 10.1161/CIRCULATIONAHA.107.747642. Epub 2008 Jun 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	30 Days