Skip to main content
OpenTrials
Completed

NCT Number: NCT00910481

Balloon Pump Assisted Coronary Intervention Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Left Ventricular Dysfunction Myocardial Ischemia Vascular Diseases Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

British Cardiovascular Intervention Society

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intra-Aortic Balloon Pump

Device

Elective IABP insertion before PCI

Primary outcomes

  1. Major Adverse Cardiac and Cerebrovascular Events

    Time frame: Hospital discharge or 28 days following PCI, whichever occurs sooner

    (composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event)

Secondary outcomes

  1. All-cause Mortality

    Time frame: 6-months following randomization

  2. Major Procedural Complications

    Time frame: Duration of PCI procedure

  3. Bleeding Complications (Major and Minor)

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

  4. Access Site Complications

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

  5. Transient Ischemic Attack

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

  6. Length of Hospital Stay

    Time frame: Hospital Discharge

  7. Procedural Success

    Time frame: Duration of PCI procedure

Sponsors and collaborators

Lead sponsor

British Cardiovascular Intervention Society

Other

Registry information

Acronym: BCIS-1

Important dates

Study start
2005
Primary completion
2011
Study completion
2012
First posted
May 29, 2009
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.