ELEVATE High-Risk PCI Pivotal Study

NARecruitingINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

July 25, 2025

Primary Completion Date

March 16, 2027

Study Completion Date

September 16, 2027

Conditions
High-Risk Percutaneous Coronary Intervention (High-risk PCI)
Interventions
DEVICE

Elevate

The Elevate System is a catheter- mounted, self-expanding and retrievable, continuous-flow pump, designed to unload the left ventricle by actively transporting blood from the left ventricle into the ascending aorta, thus augmenting cardiac output and maintaining systemic arterial pressure during complex/high-risk coronary interventions. Subjects will receive an Elevate prior to their high-risk percutaneous intervention.

DEVICE

Impella

Subjects will receive an Impella prior to their high-risk percutaneous intervention.

Trial Locations (6)

10023

RECRUITING

NYU Langone/Bellevue/Long Island, New York

10029

RECRUITING

Mount Sinai, New York

10065

RECRUITING

Weill Cornell Medical Center, New York

11030

RECRUITING

North Shore University Hospital, Manhasset

33606

RECRUITING

Tampa General/USF, Tampa

41017

RECRUITING

St. Elizabeth Healthcare, Edgewood

Sponsors
All Listed Sponsors
lead

Magenta Medical Ltd.

INDUSTRY

NCT07001332 - ELEVATE High-Risk PCI Pivotal Study | Biotech Hunter | Biotech Hunter