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

CompletedOBSERVATIONAL
Enrollment

203

Participants

Timeline

Start Date

November 29, 2021

Primary Completion Date

December 19, 2023

Study Completion Date

December 19, 2023

Conditions
Coronary Artery Disease
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.

Trial Locations (11)

11042

Northwell / Lenox Hill & Staten Island, New Hyde Park

46402

Methodist Hospitals, Gary

48124

Ascension - St. John, Dearborn

48202

Henry Ford Health System, Detroit

77021

Memorial Hermann NE / TCR Institute, Kingwood

77030

Memorial Hermann / UTH, Houston

St. Luke's / Texas Heart, Houston

85013

St. Joseph Hospital / Arizona Heart, Phoenix

85719

Tucson Medical Center / PIMA Heart, Tucson

08837

Hackensack Meridian Health, Edison

07960

Morristown Medical Center, Morristown

All Listed Sponsors
collaborator

Proxima CRO

INDUSTRY

collaborator

Cardiovascular Research Foundation, New York

OTHER

lead

Saranas, Inc.

INDUSTRY

NCT05077657 - Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System | Biotech Hunter | Biotech Hunter