Balloon Pump Assisted Coronary Intervention Study

Coronary Artery Disease Clinical Trial

— BCIS-1  

Official title:

Balloon Pump Assisted Coronary Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910481
• Other study ID #: ISRCTN40553718
• Secondary ID: ISRCTN40553718
• Status: Completed
• Phase: N/A
• Start date: December 2005
• Est. completion date: December 2012

Study information

• Verified date: February 2021
• Source: British Cardiovascular Intervention Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: December 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Left Ventricular Dysfunction
• Myocardial Ischemia
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Device:
• Intra-Aortic Balloon Pump
Elective IABP insertion before PCI

Locations

Country	Name	City	State
United Kingdom	British Cardiovascular Intervention Society	London

Sponsors (1)

Lead Sponsor	Collaborator
British Cardiovascular Intervention Society

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Perera D, Stables R, Clayton T, De Silva K, Lumley M, Clack L, Thomas M, Redwood S; BCIS-1 Investigators. Long-term mortality data from the balloon pump-assisted coronary intervention study (BCIS-1): a randomized, controlled trial of elective balloon coun — View Citation

Perera D, Stables R, Thomas M, Booth J, Pitt M, Blackman D, de Belder A, Redwood S; BCIS-1 Investigators. Elective intra-aortic balloon counterpulsation during high-risk percutaneous coronary intervention: a randomized controlled trial. JAMA. 2010 Aug 25; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac and Cerebrovascular Events	(composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event)	Hospital discharge or 28 days following PCI, whichever occurs sooner
Secondary	All-cause Mortality		6-months following randomization
Secondary	Major Procedural Complications		Duration of PCI procedure
Secondary	Bleeding Complications (Major and Minor)		Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Secondary	Access Site Complications		Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Secondary	Transient Ischemic Attack		Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Secondary	Length of Hospital Stay		Hospital Discharge
Secondary	Procedural Success		Duration of PCI procedure