Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Saranas, Inc.
With
Proxima CRO
Cardiovascular Research Foundation, New York
To demonstrate that patients undergoing complex high-risk PCI using MCS and surveillance with the Saranas Early Bird Bleed Monitoring System will have relative incidence rate reduction of access site related BARC type III or V bleeding. An optimal outcome will show a a reduction in access-site related bleeding rate when using MCS with the Saranas EBBMS in high-risk PCI patients compared to historical incidence rate.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
≥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.
You may not be if
Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
Active bleeding
Incapacity to access safely femoral artery or femoral vein
Significant femoral, iliac, abdominal, or thoracic aortic disease which precludes placement of MCS
Anemia (Hgb \<9 g/dL), thrombocytopenia (Plt \<50,000 cell/mL), history of bleeding diathesis or coagulopathy, or hypercoagulable states
Active infection not controlled with antibiotic therapy
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
