Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System

Prior treatment

• Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication

Other illness

• Active bleeding
• Significant femoral, iliac, abdominal, or thoracic aortic disease which precludes placement of MCS
• Active infection not controlled with antibiotic therapy

Lab values

• Anemia (Hgb \<9 g/dL), thrombocytopenia (Plt \<50,000 cell/mL), history of bleeding diathesis or coagulopathy, or hypercoagulable states

Other

• Incapacity to access safely femoral artery or femoral vein
• Currently pregnant or women of child-bearing potential without documented negative pregnancy test
• Estimated life expectancy \< 24 hours
• Patient is in cardiogenic shock at the time of enrollment

• ≥18 years of age
• Planned complex high-risk PCI using MCS with Impella from a femoral access and use of Saranas Early Bird Bleed Monitoring System
• 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.