Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Early Bird® Bleed Monitoring SystemDevice: Impella®
- Registration Number
- NCT05077657
- Lead Sponsor
- Saranas, Inc.
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 203
- ≥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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Single-Arm Early Bird® Bleed Monitoring System This is a multi-center, single arm, open-label study to evaluate the safety of complex high-risk PCI using Impella and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS). Single-Arm Impella® This is a multi-center, single arm, open-label study to evaluate the safety of complex high-risk PCI using Impella and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS).
- Primary Outcome Measures
Name Time Method Incidence of access site related BARC type III or V bleeding Within 24 hours
- Secondary Outcome Measures
Name Time Method Incidence of activation of each Saranas Early Bird level 1, 2 and 3 indicator Within 24 hours Incidence of all BARC type III or V bleeding Within 24 hours
Trial Locations
- Locations (11)
Northwell / Lenox Hill & Staten Island
🇺🇸New Hyde Park, New York, United States
Methodist Hospitals
🇺🇸Gary, Indiana, United States
Memorial Hermann NE / TCR Institute
🇺🇸Kingwood, Texas, United States
Ascension - St. John
🇺🇸Dearborn, Michigan, United States
St. Luke's / Texas Heart
🇺🇸Houston, Texas, United States
Memorial Hermann / UTH
🇺🇸Houston, Texas, United States
St. Joseph Hospital / Arizona Heart
🇺🇸Phoenix, Arizona, United States
Hackensack Meridian Health
🇺🇸Edison, New Jersey, United States
Tucson Medical Center / PIMA Heart
🇺🇸Tucson, Arizona, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States