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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Early Bird® Bleed Monitoring System
* Device: Impella®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single-Arm<br>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). | Device: Early Bird® Bleed Monitoring System<br>* The Early Bird Bleed Monitoring System is used in endovascular procedures to monitor and detect internal bleeding complications in real-time.<br>Device: Impella®<br>* Impella is an FDA-approved percutaneous heart pump indicated for patients with severe coronary artery disease requiring high-risk PCI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of access site related BARC type III or V bleeding |  | Within 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Coronary Intervention