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ClearWay Rx Readmission Registry (ClearWay)

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ClinicalTrials.gov Identifier: NCT01673893
Recruitment Status : Completed
First Posted : August 28, 2012
Results First Posted : September 24, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Institute of the South Clinical Research Corporation

Study Description
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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.

Condition or disease Intervention/treatment
Acute Myocardial Infarction 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 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).

Study Design
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Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ClearWay Rx Readmission Registry
Study Start Date : September 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Groups and Cohorts
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Group/Cohort Intervention/treatment
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 - ST elevation myocardial infarction

 Device: ClearWay™ Rx catheter
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 - Non-ST elevation myocardial infarction/ACS/Unstable Angina

 Device: ClearWay™ Rx catheter


Outcome Measures
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Primary Outcome Measures :
  1. 30 Day Readmissions [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients presenting with myocardial infarction
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673893


Locations
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United States, Louisiana
Cardiovascular Institute of the South Clinical Research Corporation
Lafayette, Louisiana, United States, 70503
Sponsors and Collaborators
Cardiovascular Institute of the South Clinical Research Corporation
Investigators
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Principal Investigator: Nick Cavros, MD Cardiovascular Institute of the South
More Information
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Publications:

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Responsible Party: Cardiovascular Institute of the South Clinical Research Corporation
ClinicalTrials.gov Identifier: NCT01673893    
Other Study ID Numbers: K061680
First Posted: August 28, 2012    Key Record Dates
Results First Posted: September 24, 2018
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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
Medicare
 Medicaid
Registry
catheterization
readmission
Acute Coronary Syndrome
ClearwayRx Catheter
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases