MINI-AMI: Minimizing Infarct Size With Impella 2.5 Following PCI for Acute Myocardial Infarction

The primary objective of this study is to evaluate whether the adjunctive use of the
IMPELLA® 2.5 System for 24 hours following primary PCI for STEMI has the potential to limit
the infarction of at-risk myocardium compared to primary PCI with routine post-PCI care
(standard of care). This study is a feasibility study. Therefore, the principal objective is
to identify trends in cardiac magnetic resonance imaging (MRI)-based efficacy outcomes
between the randomized treatment arms (Impella arm compared to control).

Inclusion Criteria:

- Age ≥ 18 years

- Signed Informed Consent

- Acute anterior STEMI with ≥2 mm of ST-segment elevation in 2 or more contiguous
anterior leads or ≥ 4 mm in total in the anterior leads, OR, Large Inferior STEMI
with ≥2 mm of ST-segment elevation in 2 or more inferior leads AND EITHER ≥1 mm
ST-segment elevation in V1 OR ≥1 mm of ST-segment depression in ≥2 contiguous
anterior leads (V1-V3)

- Primary PCI performed within 5 hours of the onset of symptoms

- Patient undergoing emergent primary PCI of one culprit lesion in one major native
epicardial coronary vessel

- Successful revascularization of the culprit native coronary artery with TIMI Flow
Grade of 3 at the end of PCI

Exclusion Criteria:

- Cardiac arrest requiring CPR within 24 hours prior to enrollment

- Current cardiogenic shock

- Left Bundle Branch Block (new or old)

- Atrial fibrillation

- Known history of prior MI

- Prior coronary artery bypass graft surgery

- Known mural thrombus in the left ventricle or contraindication to left
ventriculography

- Presence of a mechanical aortic valve

- Documented presence of moderate to severe aortic stenosis or moderate to severe
aortic insufficiency.

- Known history of severe kidney dysfunction.

- Known contraindication to MRI (implanted metallic or magnetically activated device;
claustrophobia, inability to hold breath for 15 seconds).

- History of recent (within 1 month) stroke or TIA

- History of bleeding diathesis or known coagulopathy (including heparin-induced
thrombocytopenia), or will refuse blood transfusions.

- Administration of fibrinolytic therapy within 24 hours

- Known hypersensitivity or contraindication to any of the following: Heparin, pork or
pork products; Aspirin, All of the following: Clopidogrel, Ticlopidine, Prasugrel

- Contrast media Participation in the active treatment or follow-up phase of another
clinical study of an investigational drug or device.

- Severe peripheral arterial obstructive disease that would preclude the IMPELLA®
System placement

- Requirement to treat two or more culprit vessels during primary PCI, or plan for
staged coronary revascularization (PCI or CABG) within the next 30 days.

- Inability to place Impella within 6 hours of the onset of symptoms, should patient be
randomized to this arm.