ClearWay Rx Readmission Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Cardiovascular Institute of the South Clinical Research Corporation
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Institute of the South Clinical Research Corporation
ClinicalTrials.gov Identifier:
NCT01673893
First received: August 24, 2012
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Acute Myocardial Infarction
Device: ClearWay™ Rx catheter

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ClearWay Rx Readmission Registry

Resource links provided by NLM:


Further study details as provided by Cardiovascular Institute of the South Clinical Research Corporation:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
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)
Groups/Cohorts Assigned Interventions
Readmission Results
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

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 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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients presenting with myocardial infarction

Criteria

Inclusion Criteria:

  • Acute Coronary Syndrome (STEMI or NSTEMI) 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673893

Contacts
Contact: Shontel Cleveland, LPN 337-291-6961 shontel.cleveland@cardio.com
Contact: Nick Cavros, MD 337-289-8429 nick.cavros@cardio.com

Locations
United States, Louisiana
Cardiovascular Institute of the South Clinical Research Corporation Recruiting
Lafayette, Louisiana, United States, 70503
Contact: Shontel Cleveland, LPN    337-291-6961    shontel.cleveland@cardio.com   
Contact: Nick Cavros, MD    337-289-8429    nick.cavros@cardio.com   
Principal Investigator: Nick Cavros, MD         
Sponsors and Collaborators
Cardiovascular Institute of the South Clinical Research Corporation
Investigators
Principal Investigator: Nick Cavros, MD Cardiovascular Institute of the South
  More Information

No publications provided

Responsible Party: Cardiovascular Institute of the South Clinical Research Corporation
ClinicalTrials.gov Identifier: NCT01673893     History of Changes
Other Study ID Numbers: K061680
Study First Received: August 24, 2012
Last Updated: May 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cardiovascular Institute of the South Clinical Research Corporation:
ClearWay
Glycoprotein
Primary Coronary Intervention
Abciximab
ST Elevation Myocardial Infarction
Non-ST Elevation Myocardial Infarction
STEMI
NSTEMI
Medicare
Medicaid
Registry
catheterization
readmission
Acute Coronary Syndrome
ClearwayRx Catheter

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 14, 2014