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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
301
Elective IABP insertion before PCI
British Cardiovascular Intervention Society
London, United Kingdom
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
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
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