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

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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Early Bird® Bleed Monitoring System; Device: Impella®

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 Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph Hospital / Arizona Heart
    • Tucson, Arizona, United States, 85719
      • Tucson Medical Center / PIMA Heart
  • Indiana
    • Gary, Indiana, United States, 46402
      • Methodist Hospitals
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Ascension - St. John
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • New Jersey
    • Edison, New Jersey, United States, 08837
      • Hackensack Meridian Health
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
  • New York
    • New Hyde Park, New York, United States, 11042
      • Northwell / Lenox Hill & Staten Island
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann / UTH
    • Houston, Texas, United States, 77030
      • St. Luke's / Texas Heart
    • Kingwood, Texas, United States, 77021
      • Memorial Hermann NE / TCR Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing complex high-risk percutaneous coronary intervention (PCI) with mechanical circulatory support (MCS) via Impella® and transfemoral arterial approach will be enrolled. The Saranas Early Bird Bleed Monitoring System will be used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	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.; Device: Impella®; Impella is an FDA-approved percutaneous heart pump indicated for patients with severe coronary artery disease requiring high-risk PCI.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access site related bleeding complications	Safety Endpoint	Within 24 hours
Access site related vascular complications	Safety Endpoint	Within 24 hours
Access site related blood transfusions	Safety Endpoint	Within 24 hours
Non-access site related bleeding complications	Safety Endpoint	Within 24 hours
Non-access site related vascular complications	Safety Endpoint	Within 24 hours
Non-access site related blood transfusions	Safety Endpoint	Within 24 hours
All blood transfusions	Safety Endpoint	Within 24 hours
Hemoglobin drop	Safety Endpoint	Within 24 hours
Death	Safety Endpoint	Within 24 hours
Device and procedure-related adverse events	Safety Endpoint	Within 24 hours
Serious adverse events	Safety Endpoint	Within 24 hours
Serious adverse device effects	Safety Endpoint	Within 24 hours

Collaborators and Investigators

• Sponsor: Saranas, Inc.
• Collaborators: Cardiovascular Research Foundation, New York; Proxima Clinical Research, Inc.
• Investigators: Principal Investigator: Mir Basir, DO, Henry Ford Hospital; Principal Investigator: Philippe Généreux, MD, Gagnon Cardiovascular Institute - Morristown Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: PVP012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No