The Magenta Elevate™ High-Risk PCI Pivotal Study (Elevate III)

To evaluate the safety and effectiveness of Magenta Elevate™ compared with Impella® in subjects undergoing non-emergent, MCS-supported HR-PCI. The Primary Outcome Measure will be assessed by comparing the incidence of a composite of major safety adverse events and effectiveness parameters through 30 days.

For more information, visit: https://clinicaltrials.gov/study/NCT07001332

Inova Health Care Services                                                                   
3300 Gallows Road                                                                               
Falls Church, VA 22042

•      Non-emergent, PCI is planned in at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis).
•      Ejection fraction of ≤ 50%.
•      At least one of the following high-risk characteristics:
  • Intervention on an unprotected Left Main (LM) coronary artery.
  • Intervention on a LM equivalent, i.e., anatomical variations that place a large proportion of live myocardium at risk
  • Intervention on a last patent coronary conduit (native or graft).                                                                     Three-vessel disease (in case of left coronary artery dominance, the combination of an LAD lesion and a proximal Cx lesion qualifies as three-vessel disease).

•        Age < 18 or ≥ 89 years.
•        Myocardial infarction (MI); or ST-elevation MI (STEMI) within 72 hours prior to enrollment.
•        Cardiac arrest requiring cardiopulmonary resuscitation or defibrillation within 72 hours of enrollment
•        Cardiogenic shock; acutely decompensated pre-existing chronic heart failure; any use of inotropes/vasopressors in the previous 48 hours; OR any use of mechanical circulatory support within 14 days.