Balloon Pump Assisted Coronary Intervention Study

Not Applicable

Completed

• Conditions: Left Ventricular Dysfunction; Coronary Artery Disease
• Interventions: Device: Intra-Aortic Balloon Pump

• Registration Number: NCT00910481
• Lead Sponsor: British Cardiovascular Intervention Society

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-05-29
• Primary Completion: 2011-01
• Study Completion: 2012-12
• Results First Submitted: 2021-02-06
• Results First Submitted QC: 2021-02-06
• Results First Posted: 2021-02-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elective IABP Insertion	Intra-Aortic Balloon Pump	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

British Cardiovascular Intervention Society; 🇬🇧 London, United Kingdom