Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System
Safe-MCS is an observational study with the objective to establish the safety of complex high-risk Percutaneous Coronary Intervention (PCI) using Mechanical Circulatory Support (MCS) and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS).
PI:Dr. Jorge M. Escobar
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SPONSOR: Saranas, INC
1. ≥18 years of age
2. Planned complex high-risk PCI using MCS with Impella from a femoral access and use of Saranas Early Bird Bleed Monitoring System
3. The study patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the institutional review board of the respective clinical site.