Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System (SAFE-MCS)

Saranas

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Early Bird® Bleed Monitoring System; Device: Impella®

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05077657

PVP012

Details and patient eligibility

About

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).

Full 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.

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

203 participants in 1 patient group

Single-Arm

Description:

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).

Treatment:

Device: Impella®

Device: Early Bird® Bleed Monitoring System