N/A
Completed N=301
Balloon Pump Assisted Coronary Intervention Study
Source: ClinicalTrials.gov NCT00910481 ↗Enrolled (actual)
301
Serious AEs
0.7%
Results posted
Feb 2021
Primary outcomePrimary: Major Adverse Cardiac and Cerebrovascular Events — 23; 24 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Cardiac and Cerebrovascular Events |
23; 24 | — |
| SECONDARY All-cause Mortality |
— | — |
| SECONDARY Major Procedural Complications |
— | — |
| SECONDARY Bleeding Complications (Major and Minor) |
— | — |
| SECONDARY Access Site Complications |
— | — |
| SECONDARY Transient Ischemic Attack |
— | — |
| SECONDARY Length of Hospital Stay |
— | — |
| SECONDARY Procedural Success |
— | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00910481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.