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

Coronary Artery Disease Clinical Trial

— SAFE-MCS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05077657
• Other study ID #: PVP012
• Status: Completed
• Start date: November 29, 2021
• Est. completion date: December 19, 2023

Study information

• Verified date: February 2024
• Source: Saranas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
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	Methodist Hospitals	Gary	Indiana
United States	Memorial Hermann / UTH	Houston	Texas
United States	St. Luke's / Texas Heart	Houston	Texas
United States	Memorial Hermann NE / TCR Institute	Kingwood	Texas
United States	Morristown Medical Center	Morristown	New Jersey
United States	Northwell / Lenox Hill & Staten Island	New Hyde Park	New York
United States	St. Joseph Hospital / Arizona Heart	Phoenix	Arizona
United States	Tucson Medical Center / PIMA Heart	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Saranas, Inc.	Cardiovascular Research Foundation, New York, Proxima Clinical Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Access site related bleeding complications	Safety Endpoint	Within 24 hours
Other	Access site related vascular complications	Safety Endpoint	Within 24 hours
Other	Access site related blood transfusions	Safety Endpoint	Within 24 hours
Other	Non-access site related bleeding complications	Safety Endpoint	Within 24 hours
Other	Non-access site related vascular complications	Safety Endpoint	Within 24 hours
Other	Non-access site related blood transfusions	Safety Endpoint	Within 24 hours
Other	All blood transfusions	Safety Endpoint	Within 24 hours
Other	Hemoglobin drop	Safety Endpoint	Within 24 hours
Other	Death	Safety Endpoint	Within 24 hours
Other	Device and procedure-related adverse events	Safety Endpoint	Within 24 hours
Other	Serious adverse events	Safety Endpoint	Within 24 hours
Other	Serious adverse device effects	Safety Endpoint	Within 24 hours
Primary	Incidence of access site related BARC type III or V bleeding		Within 24 hours
Secondary	Incidence of activation of each Saranas Early Bird level 1, 2 and 3 indicator		Within 24 hours
Secondary	Incidence of all BARC type III or V bleeding		Within 24 hours