Balloon Pump Assisted Coronary Intervention Study

NCT00910481 | Completed Results DMC

• 1 other identifier: ISRCTN40553718
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Left Ventricular Dysfunction

Keywords

Coronary Artery Disease; Percutaneous Transluminal Coronary Angioplasty; Intraaortic Balloon Pumping; Left Ventricular Dysfunction; High Risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• All-cause Mortality

  6-months following randomization

• Major Procedural Complications

  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)

• Transient Ischemic Attack

  Hospital Discharge or 28 days following PCI (whichever occurs sooner)

Study Arms (2)

Elective IABP Insertion

EXPERIMENTAL

Device: Intra-Aortic Balloon Pump

No Planned IABP Insertion

NO INTERVENTION

Interventions

Intra-Aortic Balloon Pump DEVICE

Elective IABP insertion before PCI

Elective IABP Insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• impaired left ventricular function (Ejection Fraction \< 30%)
• large area of myocardium at risk (BCIS-1 Myocardial Jeopardy Score ≥ 8/12)

You may not qualify if:

• 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)

Sponsors & Collaborators

• British Cardiovascular Intervention Society: lead

Study Sites (1)

British Cardiovascular Intervention Society

London, United Kingdom

Location

Related Publications (3)

• 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 counterpulsation during high-risk percutaneous coronary intervention. Circulation. 2013 Jan 15;127(2):207-12. doi: 10.1161/CIRCULATIONAHA.112.132209. Epub 2012 Dec 6.

  PMID: 23224207 RESULT

• 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;304(8):867-74. doi: 10.1001/jama.2010.1190.

  PMID: 20736470 RESULT

• Perera D, Stables R, Booth J, Thomas M, Redwood S; BCIS-1 Investigators. The balloon pump-assisted coronary intervention study (BCIS-1): rationale and design. Am Heart J. 2009 Dec;158(6):910-916.e2. doi: 10.1016/j.ahj.2009.09.015.

  PMID: 19958856 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Ventricular Dysfunction, Left

Interventions

Intra-Aortic Balloon Pumping

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Counterpulsation; Assisted Circulation; Surgical Procedures, Operative

Results Point of Contact

• Title: Professor Divaka Perera
• Organization: King's College London

divaka.perera@kcl.ac.uk

02071887188

Study Officials

• Divaka Perera, MRCP, MD

  Guy's and St Thomas' Hospital NHSFT, London, UK

  PRINCIPAL INVESTIGATOR

• Simon Redwood, FRCP, MD

  Guy's and St Thomas' Hospital NHSFT, London, UK

  PRINCIPAL INVESTIGATOR

• Rodney Stables, FRCP, DM

  Liverpool Cardiothoracic Centre, Liverpool, UK

  PRINCIPAL INVESTIGATOR

• Martyn Thomas, FRCP, MD

  Guy's and St Thomas' Hospital NHSFT, London, UK

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: May 29, 2009
• Study Start: December 1, 2005
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2012
• Last Updated: August 7, 2024
• Results First Posted: February 25, 2021

Record last verified: 2024-08

Locations

GB (1)