Balloon pump assisted Coronary Intervention Study

Not Applicable

Completed

• Conditions: Multi-vessel coronary artery disease; Circulatory System; Chronic ischaemic heart disease

• Registration Number: ISRCTN40553718
• Lead Sponsor: British Cardiovascular Intervention Society

Brief Summary

2009 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/19958856 protocol 2010 Results article in http://www.ncbi.nlm.nih.gov/pubmed/20736470 results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23224207 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2006-07-30
• Study Start: 2007-02-13
• Last Update Posted: 20 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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
9. Active internal bleeding (except menstruation)
10. Allergy to aspirin, clopidogrel, heparin or Glycoprotein (GP) IIb/IIIa inhibitors
11. Thrombocytopenia (platelet count less than 100,000 cells/mm^3)
12. Women who are pregnant
13. Patients who have previously been enrolled in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified