Coronary Artery Disease
Conditions
Keywords
Patient undergoing scheduled PCI
Brief summary
The IMPELLA® 2.5 System will be superior to Intra Aortic Balloon Pump in preventing the composite rate of major adverse events during and after the PCI procedure.
Interventions
DEVICEIMPLELLA LP 2.5
Insertion of the LP 2.5 IMPELLA circulatory support system that can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta at 2.5 L/min.
IABP uses counterpulsation to provide 0.2L/min coronary flow
Sponsors
Abiomed Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent * Subject is indicated for a NON emergent percutaneous treatment of at least on de novo or restenotic lesion in a native coronary vessel or bypass graft. * Patient presents with: * A compromised Ejection Fraction * Intervention on the last patent coronary conduit * Intervention on an unprotected left main artery or * Patient presenting with triple vessel disease.
Exclusion criteria
* ST elevation M.I. * Pre procedure cardiac arrest within 24 hours. * Subject in cardiogenic shock
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization. | 30 days +/- 10 days |
Secondary
| Measure | Time frame |
|---|---|
| Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP. | In hospital events |
Countries
Canada, Netherlands, United States
Outcome results
None listed