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

Sponsor
Saranas, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05077657
Collaborator
Proxima Clinical Research, Inc. (Other), Cardiovascular Research Foundation, New York (Other)
265
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13.1
20.3

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational
Anticipated 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 :
Nov 29, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Incidence of access site related BARC type III or V bleeding [Within 24 hours]

Secondary Outcome Measures

  1. Incidence of activation of each Saranas Early Bird level 1, 2 and 3 indicator [Within 24 hours]

  2. Incidence of all BARC type III or V bleeding [Within 24 hours]

Other Outcome Measures

  1. Access site related bleeding complications [Within 24 hours]

    Safety Endpoint

  2. Access site related vascular complications [Within 24 hours]

    Safety Endpoint

  3. Access site related blood transfusions [Within 24 hours]

    Safety Endpoint

  4. Non-access site related bleeding complications [Within 24 hours]

    Safety Endpoint

  5. Non-access site related vascular complications [Within 24 hours]

    Safety Endpoint

  6. Non-access site related blood transfusions [Within 24 hours]

    Safety Endpoint

  7. All blood transfusions [Within 24 hours]

    Safety Endpoint

  8. Hemoglobin drop [Within 24 hours]

    Safety Endpoint

  9. Death [Within 24 hours]

    Safety Endpoint

  10. Device and procedure-related adverse events [Within 24 hours]

    Safety Endpoint

  11. Serious adverse events [Within 24 hours]

    Safety Endpoint

  12. Serious adverse device effects [Within 24 hours]

    Safety Endpoint

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Morristown Medical Center Morristown New Jersey United States 07960

Sponsors and Collaborators

  • Saranas, Inc.
  • Proxima Clinical Research, Inc.
  • Cardiovascular Research Foundation, New York

Investigators

  • Principal Investigator: Mir Basir, DO, Henry Ford Hospital
  • Principal Investigator: Philippe Généreux, MD, Gagnon Cardiovascular Institute - Morristown Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Saranas, Inc.
ClinicalTrials.gov Identifier:
NCT05077657
Other Study ID Numbers:
  • PVP012
First Posted:
Oct 14, 2021
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 25, 2022