NCT01673893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

September 24, 2018

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

2.6 years

First QC Date

August 24, 2012

Results QC Date

January 25, 2017

Last Update Submit

November 1, 2018

Conditions

Acute Myocardial Infarction

Keywords

ClearWayGlycoproteinPrimary Coronary InterventionAbciximabST Elevation Myocardial InfarctionNon-ST Elevation Myocardial InfarctionMedicareMedicaidRegistrycatheterizationreadmissionAcute Coronary SyndromeClearwayRx Catheter

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Interventions

ClearWay™ Rx catheterDEVICE
Non-ST elevation myocardial infarction/ACS/UNSTABLE ANGINAST elevation myocardial infarction

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients presenting with myocardial infarction

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Institute of the South Clinical Research Corporation

Lafayette, Louisiana, 70503, United States

Location

Related Publications (5)

  • Krumholz, et al. Circulation 2009; 2:407-413.

    BACKGROUND

  • Thiele, et al. Circulation 2008 Vol. 118

    BACKGROUND

  • 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. doi: 10.1007/s11239-006-9000-0.

    PMID: 17160551BACKGROUND

  • Hassan, et al. American Heart Journal. Volume 154;2:345-351.

    BACKGROUND

  • 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.

    PMID: 19712799BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionNon-ST Elevated Myocardial InfarctionAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Results Point of Contact

Title
Deanna K. Benoit, LPN, CCRC
Organization
Cardiovascular Institute of the South Clinical Research Corporation
deanna.benoit@cardio.com
985-876-0300

Study Officials

  • Nick Cavros, MD

    Cardiovascular Institute of the South

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2012

First Posted

August 28, 2012

Study Start

September 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

November 29, 2018

Results First Posted

September 24, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)