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

Completed

Conditions studied: Coronary Artery Disease

In brief

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).

Key facts

Study ID

NCT05077657

Run by

Saranas, Inc.

People needed

203

Starts

2021-11-29

Expected to finish

2023-12-19

Last updated by the study team

2024-02-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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