Balloon Pump Assisted Coronary Intervention Study

British Cardiovascular Intervention Society1 site in 1 country301 target enrollmentDecember 2005

ConditionsCoronary Artery Disease Left Ventricular Dysfunction

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: British Cardiovascular Intervention Society
Enrollment: 301
Locations: 1
Primary Endpoint: Major Adverse Cardiac and Cerebrovascular Events
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will test the hypothesis that elective use of the Intra-Aortic Balloon Pump (IABP) in patients undergoing high-risk Percutaneous Coronary Intervention (PCI) will reduce the rate of in-hospital major adverse cardiac and cerebrovascular events compared to patients who are managed without planned insertion of IABP.

Registry

clinicaltrials.gov

Start Date

December 2005

End Date

December 2012

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

British Cardiovascular Intervention Society

Responsible Party

Principal Investigator

Dr Divaka Perera

Professor of Cardiology

British Cardiovascular Intervention Society

Eligibility Criteria

Inclusion Criteria

•impaired left ventricular function (Ejection Fraction \< 30%)
•large area of myocardium at risk (BCIS-1 Myocardial Jeopardy Score ≥ 8/12)

Exclusion Criteria

•cardiogenic shock
•acute STEMI within previous 48 hours
•complications of recent AMI (including ventricular septal defect, severe mitral regurgitation, intractable ventricular arrhythmias)
•contraindications to IABP use (including significant iliac or femoral arterial disease and more than mild aortic regurgitation)

Outcomes

Primary Outcomes

Major Adverse Cardiac and Cerebrovascular Events

Time Frame: Hospital discharge or 28 days following PCI, whichever occurs sooner

(composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event)

Secondary Outcomes

All-cause Mortality(6-months following randomization)
Major Procedural Complications(Duration of PCI procedure)
Transient Ischemic Attack(Hospital Discharge or 28 days following PCI (whichever occurs sooner))
Procedural Success(Duration of PCI procedure)
Bleeding Complications (Major and Minor)(Hospital Discharge or 28 days following PCI (whichever occurs sooner))
Access Site Complications(Hospital Discharge or 28 days following PCI (whichever occurs sooner))
Length of Hospital Stay(Hospital Discharge)