Coronary Artery Disease
Conditions
Keywords
Percutaneous Coronary Intervention
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.
Interventions
DEVICEEarly Bird® Bleed Monitoring System
The Early Bird Bleed Monitoring System is used in endovascular procedures to monitor and detect internal bleeding complications in real-time.
DEVICEImpella®
Impella is an FDA-approved percutaneous heart pump indicated for patients with severe coronary artery disease requiring high-risk PCI.
Sponsors
Proxima CRO
Cardiovascular Research Foundation, New York
Saranas, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of access site related BARC type III or V bleeding | Within 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Access site related vascular complications | Within 24 hours | Safety Endpoint |
| Access site related bleeding complications | Within 24 hours | Safety Endpoint |
| Non-access site related blood transfusions | Within 24 hours | Safety Endpoint |
| All blood transfusions | Within 24 hours | Safety Endpoint |
| Access site related blood transfusions | Within 24 hours | Safety Endpoint |
| Death | Within 24 hours | Safety Endpoint |
| Device and procedure-related adverse events | Within 24 hours | Safety Endpoint |
| Serious adverse events | Within 24 hours | Safety Endpoint |
| Serious adverse device effects | Within 24 hours | Safety Endpoint |
| Hemoglobin drop | Within 24 hours | Safety Endpoint |
| Non-access site related bleeding complications | Within 24 hours | Safety Endpoint |
| Non-access site related vascular complications | Within 24 hours | Safety Endpoint |
Countries
United States
Outcome results
None listed