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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-29

Study Completion Date

2023-12-19

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).

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Single-Arm

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).

Early Bird® Bleed Monitoring System

Intervention Type DEVICE

The Early Bird Bleed Monitoring System is used in endovascular procedures to monitor and detect internal bleeding complications in real-time.

Impella®

Intervention Type DEVICE

Impella is an FDA-approved percutaneous heart pump indicated for patients with severe coronary artery disease requiring high-risk PCI.

Interventions

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Early 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.

Intervention Type DEVICE

Impella®

Impella is an FDA-approved percutaneous heart pump indicated for patients with severe coronary artery disease requiring high-risk PCI.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No