The objective of this study is 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).
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.
Study Type
OBSERVATIONAL
Enrollment
203
The Early Bird Bleed Monitoring System is used in endovascular procedures to monitor and detect internal bleeding complications in real-time.
Impella is an FDA-approved percutaneous heart pump indicated for patients with severe coronary artery disease requiring high-risk PCI.
St. Joseph Hospital / Arizona Heart
Phoenix, Arizona, United States
Tucson Medical Center / PIMA Heart
Tucson, Arizona, United States
Methodist Hospitals
Gary, Indiana, United States
Incidence of access site related BARC type III or V bleeding
Time frame: Within 24 hours
Incidence of activation of each Saranas Early Bird level 1, 2 and 3 indicator
Time frame: Within 24 hours
Incidence of all BARC type III or V bleeding
Time frame: Within 24 hours
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Ascension - St. John
Dearborn, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Hackensack Meridian Health
Edison, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
Northwell / Lenox Hill & Staten Island
New Hyde Park, New York, United States
Memorial Hermann / UTH
Houston, Texas, United States
St. Luke's / Texas Heart
Houston, Texas, United States
...and 1 more locations