ELEVATE High-Risk PCI Pivotal Study

Recruiting now · Not applicable

Conditions studied: High-Risk Percutaneous Coronary Intervention (High-risk PCI)

In brief

The ELEVATE III Pivotal Study is a prospective, multi-center, open-label, interventional, randomized, controlled study with an active control group. The study is intended to assess the safety and efficacy of the Elevate™ percutaneous Left Ventricular Assist Device System in patients referred to high-risk percutaneous coronary interventions (HR-PCI).

Key facts

Study ID

NCT07001332

Run by

Magenta Medical Ltd.

People needed

290

Starts

2025-07-25

Expected to finish

2027-09-16

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older, up to 88. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Non-emergent, percutaneous coronary intervention is planned on at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis).
• A heart team that includes an interventional cardiologist and cardiac surgeon has determined that HR- PCI is an appropriate therapeutic option.
• Participant signed the informed consent.

You may not qualify if…

• Cardiogenic shock or acutely decompensated pre-existing chronic heart failure.
• Prior stroke with any permanent, significant (mRS>2) neurological deficit, or stroke or TIA within 3 months prior to enrollment.
• Any condition or scheduled surgery that will require discontinuation of the antiplatelet and/or anticoagulation therapy within 90 days of the index procedure.
• Evidence of left ventricular thrombus.
• Aortic valve stenosis/calcification (valve area ≤ 1.5 cm2).
• ≥ Moderate aortic valve regurgitation (≥ 2+ on a 4-grade scale by transthoracic echocardiography).
• Femoral access site incompatibility that precludes placement of either the Treatment or Control device.
• Patient on dialysis.
• Known or suspected coagulopathy OR abnormal coagulation parameters.
• Known allergy, sensitivity or intolerance to nickel.
• Infection of the proposed procedural access site; OR suspected systemic active infection, including any fever or known active COVID-19 infection.
• Allergy, sensitivity or intolerance to heparin, or contrast media, including known heparin-induced thrombocytopenia (HIT).
• Any non-cardiac condition with a life expectancy < 12 months.
• Subject participation in another investigational drug or device trial (with the exception of post-market registries and observational studies, subject to Sponsor review and approval).
• Pregnancy or breast-feeding.
• Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromise the participant's ability to provide written informed consent and/or to comply with study procedures.
• Subject belongs to a vulnerable population.

Where it is running

• Banner-University Medical Center — Phoenix, Arizona, United States (enrolling)
• HonorHealth Scottsdale Shea Medical Center/HonorHealth Deer Valley Medical Center — Scottsdale, Arizona, United States (enrolling)
• UC San Diego Medical Center — La Jolla, California, United States (enrolling)
• University of California at San Francisco Medical Center/Zuckerberg San Francisco General — San Francisco, California, United States (enrolling)
• Tampa General/USF — Tampa, Florida, United States (enrolling)
• Emory University Hospital / Emory University Hospital Midtown/ Emory Saint Joseph's Hospital — Atlanta, Georgia, United States (enrolling)
• Wellstar Health System — Marietta, Georgia, United States (enrolling)
• University of Illinois at Chicago — Chicago, Illinois, United States (enrolling)
• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• St. Elizabeth Healthcare — Edgewood, Kentucky, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Brigham & Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Boston Medical Center — Boston, Massachusetts, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• UMass Memorial Medical Center — Worcester, Massachusetts, United States (enrolling)
• Henry Ford Health — Detroit, Michigan, United States (enrolling)
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States (enrolling)
• St. Luke's Hospital of Kansas City — Kansas City, Missouri, United States (enrolling)
• Atlantic Health System — Morristown, New Jersey, United States (enrolling)
• Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (enrolling)
• Maimonides Health — Brooklyn, New York, United States (enrolling)
• Buffalo General Medical Center — Buffalo, New York, United States (enrolling)
• Northwell Health — Manhasset, New York, United States (enrolling)
• NYU Langone/Bellevue/Long Island — New York, New York, United States (enrolling)
• Mount Sinai — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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