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

NCT05077657 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 203

Last updated 2024-02-16

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Proxima CRO

    collaborator INDUSTRY

  • Cardiovascular Research Foundation, New York

    collaborator OTHER

  • Saranas, Inc.

    lead INDUSTRY

Principal Investigators

  • Mir Basir, DO · Henry Ford Hospital

  • Philippe Généreux, MD · Gagnon Cardiovascular Institute - Morristown Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2023-12-19
Completion
2023-12-19
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05077657 on ClinicalTrials.gov