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A prospective, randomized, controlled multi-site feasibility trial to assess the potential role of the IMPELLA® 2.5 System in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI)

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 standard of care.

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.

Only three (3) sites enrolled in the roll in phase. A total of five (5) patients were enrolled before the study was closed out. Investigators at each site were asked to enroll two initial roll-in patients that will be treated with the IMPELLA® 2.5 System.These roll in patients were not to be part of the primary analysis.

90 days

Study close in roll in phase. Therefore, no comparison data available.

Study close in roll in phase. Therefore, no comparison data available.