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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Patients enrolled in the Impella arm will receive 24 hours of post-PCI hemodynamic support using the Impella 2.5
Standard care for STEMI patients post-PCI from ACC/AHA Guidelines
Infarct Size
Infarct size (as assessed by cardiac MRI at 3-5 days following the infarction).
Time frame: 3-5 Days post infarct
No Data for Primary or Secondary Enpoints Were Collected
Time frame: No data for primary or secondary enpoints were collected
Infarct Size
Assessment of infarct size and remodeling characteristics at 90 days post-infarct.
Time frame: 90 Days
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