This trial is active, not recruiting.

Conditions coronary artery disease, left ventricular dysfunction
Treatment intra-aortic balloon pump
Sponsor British Cardiovascular Intervention Society
Start date December 2005
End date June 2009
Trial size 301 participants
Trial identifier NCT00910481, ISRCTN40553718


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
intra-aortic balloon pump
Elective IABP insertion before PCI
(No Intervention)

Primary Outcomes

Major Adverse Cardiac and Cerebrovascular Events (composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event)
time frame: Hospital discharge or 28 days following PCI, whichever occurs sooner

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Balloon Pump Assisted Coronary Intervention Study
Principal investigator Divaka Perera, MRCP, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2009.
Information provided to ClinicalTrials.gov by British Cardiovascular Intervention Society.