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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05077657
Recruitment Status : Recruiting
First Posted : October 14, 2021
Last Update Posted : March 25, 2022
Sponsor:
Collaborators:
Proxima Clinical Research, Inc.
Cardiovascular Research Foundation, New York
Information provided by (Responsible Party):
Saranas, Inc.

Study Description
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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).

Condition or disease Intervention/treatment
Coronary Artery Disease 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 estimate a 95% confidence interval for a reduction in access-site related bleeding rate when using MCS with the Saranas Saranas Early Bird Bleed Monitoring System in high-risk PCI patients.
Study Design
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Study Type : Observational
Estimated Enrollment : 265 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System
Actual Study Start Date : November 29, 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of access site related BARC type III or V bleeding [ Time Frame: Within 24 hours ]

Secondary Outcome Measures :
  1. Incidence of activation of each Saranas Early Bird level 1, 2 and 3 indicator [ Time Frame: Within 24 hours ]
  2. Incidence of all BARC type III or V bleeding [ Time Frame: Within 24 hours ]

Other Outcome Measures:
  1. Access site related bleeding complications [ Time Frame: Within 24 hours ]
    Safety Endpoint

  2. Access site related vascular complications [ Time Frame: Within 24 hours ]
    Safety Endpoint

  3. Access site related blood transfusions [ Time Frame: Within 24 hours ]
    Safety Endpoint

  4. Non-access site related bleeding complications [ Time Frame: Within 24 hours ]
    Safety Endpoint

  5. Non-access site related vascular complications [ Time Frame: Within 24 hours ]
    Safety Endpoint

  6. Non-access site related blood transfusions [ Time Frame: Within 24 hours ]
    Safety Endpoint

  7. All blood transfusions [ Time Frame: Within 24 hours ]
    Safety Endpoint

  8. Hemoglobin drop [ Time Frame: Within 24 hours ]
    Safety Endpoint

  9. Death [ Time Frame: Within 24 hours ]
    Safety Endpoint

  10. Device and procedure-related adverse events [ Time Frame: Within 24 hours ]
    Safety Endpoint

  11. Serious adverse events [ Time Frame: Within 24 hours ]
    Safety Endpoint

  12. Serious adverse device effects [ Time Frame: Within 24 hours ]
    Safety Endpoint


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05077657


Contacts
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Contact: Zaffer Syed 713-357-1049 zaffer@saranas.com
Contact: Julia Walsh julia@saranas.com

Locations
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United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Diane Agar         
Sponsors and Collaborators
Saranas, Inc.
Proxima Clinical Research, Inc.
Cardiovascular Research Foundation, New York
Investigators
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Principal Investigator: Mir Basir, DO Henry Ford Hospital
Principal Investigator: Philippe Généreux, MD Gagnon Cardiovascular Institute - Morristown Medical Center
More Information
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Responsible Party: Saranas, Inc.
ClinicalTrials.gov Identifier: NCT05077657    
Other Study ID Numbers: PVP012
First Posted: October 14, 2021    Key Record Dates
Last Update Posted: March 25, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Saranas, Inc.:
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases