Balloon pump assisted Coronary Intervention Study

British Cardiovascular Intervention Society0 sites300 target enrollmentFebruary 13, 2007

Overview

Registry

who.int

Start Date

February 13, 2007

End Date

July 30, 2006

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

British Cardiovascular Intervention Society

•1\. Patients at least 18 years of age
•2\. Proposed single or multi\-vessel percutaneous intervention to native coronary arteries or coronary bypass grafts
•3\. Presence of BOTH the following high risk features:
•3\.1\. Impaired Left Ventricular (LV) function: Ejection Fraction (EF) less than 30% (quantified by echocardiography or LV angiography)
•3\.2\. Large area of myocardium at risk, either unprotected left main stem target lesion or Jeopardy Score more than or equal to eight, or target vessel provides collateral supply to an occluded second vessel which supplies more than 40% of myocardium
•4\. Written informed consent

•1\. Shock (systolic Blood Pressure \[BP] less than 85 mmHg despite correction of hypovolaemia)
•2\. Acute myocardial infarction within previous 48 hours defined as:
•2\.1\. chest pain or equivalent symptoms consistent with acute myocardial infarction, and
•2\.2\. New ST segment elevation of at least 1 mm in two or more contiguous Electrocardiogram (ECG) leads, persisting for more than 15 minutes, or new left bundle branch block on ECG persisting for more than 15 minutes
•3\. Planned staged intervention procedure within 28 days of index PCI
•4\. Ventricular Septal Defect (VSD)/Mitral Regurgitation (MR) or intractable Ventricular Tachycardia and Ventricular Fibrillation (VT/VF) post Myocardial Infarction (MI)
•5\. Thoracic/abdominal aortic disease
•6\. Significant ilio\-femoral artery disease (documented on Doppler studies or ilio\-femoral angiography or absent femoral pulses bilaterally), the presence of clinical signs of acute leg ischaemia and previous bilateral femoral bypass graft surgery
•7\. More than mild aortic regurgitation on echocardiography
•8\. Bleeding diathesis or Warfarin therapy with International Normalised Ratio (INR) more than 2\.5