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

Philippe Généreux¹, Amir Kaki², Mostafa Naguib¹, Brittany Fuller³, Hursh Naik⁴, Michael Kim⁵, Amirali Masoumi¹, Thomas Waggoner⁶, Zaffer Syed⁷, Julia Walsh⁷, Dimitri Karmpaliotis¹, Mir Babar Basir³

¹Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey.

²Ascension St. John Hospital, Detroit, Michigan.

³Henry Ford Health System, Detroit, Michigan.

⁴St. Joseph's Medical Center, Phoenix, Arizona.

⁵Lenox Hill Hospital, Northwell Health, New York, New York.

⁶USHV Heart & Vascular, Tucson Medical Center, Tucson, Arizona.

⁷Saranas, Inc, Houston, Texas.

PubMed PMC DOI PDF

Abstract

BACKGROUND: High-risk percutaneous coronary intervention (PCI) with mechanical circulatory support (MCS) has been associated with varying rates of bleeding due to variable bleeding definitions, incomplete data relative to site-specific bleeding, and inclusion of variable patient populations. STUDY DESIGN AND OBJECTIVES: SAFE-MCS (NCT05077657) is a multicenter, single-arm, open-label study designe…

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