Impella investigational trial for non-emergent high-risk PCI patients.

The purpose of the Impella investigational trial study is to assess the safety and efficacy of a miniaturized percutaneous circulatory support system compared to an intra-aortic balloon pump (IABP) in non-emergent high-risk PCI patients. Nationwide, 654 subjects will be recruited for this study. The treatment will be assigned randomly.

You may be eligible for this study if you:

• Are between 18 and 90 years of age
• Indicated for NON-emergent percutaneous treatment
• Have an Ejection Fraction of 35% or less AND one of the following:
  • Intervention on the last patent coronary conduit, or
  • Intervention on an unprotected left main coronary artery

OR

• Have an Ejection Fraction of 30% or less and intervention in patient with triple vessel disease

You are not eligible for this study if you:

• Have a ST Myocardial Infarction or pre-procedure cardiac arrest requiring CPR within 24 hours of enrollment

• Are in cardiogenic shock (defined as CI less than 2.2 l/min/m2 and PCWP greater than 15mmHg, hypotension, and end organ hypoperfusion)

• Have Renal Failure

• Have a mechanical aortic valve, heart constrictive device, or aortic stenosis (graded as greater than +2)

This is a partial list of eligibility and exclusion criteria. To inquire whether you are eligible for this study, please call the contact number provided. If you choose to inquire via e-mail, please refer to the study title in your correspondence.