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

Completed

• Conditions: Coronary Artery Disease

• 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.

Study Timeline

• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-14
• Study Start: 2021-11-29
• Primary Completion: 2023-12-19
• Study Completion: 2023-12-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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)

St. Joseph Hospital / Arizona Heart; 🇺🇸 Phoenix, Arizona, United States

Tucson Medical Center / PIMA Heart; 🇺🇸 Tucson, Arizona, United States

Methodist Hospitals; 🇺🇸 Gary, Indiana, United States

Ascension - St. John; 🇺🇸 Dearborn, Michigan, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Hackensack Meridian Health; 🇺🇸 Edison, New Jersey, United States

Morristown Medical Center; 🇺🇸 Morristown, New Jersey, United States

Northwell / Lenox Hill & Staten Island; 🇺🇸 New Hyde Park, New York, United States

Memorial Hermann / UTH; 🇺🇸 Houston, Texas, United States

St. Luke's / Texas Heart; 🇺🇸 Houston, Texas, United States

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