RECRUITING Not applicable ClinicalTrials.gov

ELEVATE High-Risk PCI Pivotal Study

Sponsor: Magenta Medical Ltd. • ClinicalTrials.gov ID: NCT07001332

Registry updated: 2026-10-09

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Description

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).

Interventions

Elevate (Device)
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.
Impella (Device)
Subjects will receive an Impella prior to their high-risk percutaneous intervention.

Eligibility criteria

Inclusion Criteria: 1. 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). 2. Baseline (uncorrected) hemoglobin \>10.0 g/dl as long as an active source of blood loss has been reasonably excluded. 3. A heart team that includes an interventional cardiologist and cardiac surgeon has determined that HR- PCI is an appropriate therapeutic option. 4. Participant signed the informed consent. Exclusion Criteria: 1. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure. 2. Prior stroke with any permanent, significant (mRS\>2) neurological deficit, or stroke or TIA within 3 months prior to enrollment. 3. Any condition or scheduled surgery that will require discontinuation of the antiplatelet and/or anticoagulation therapy within 90 days of the index procedure. 4. Evidence of left ventricular thrombus. 5. Aortic valve stenosis/calcification (valve area ≤ 1.5 cm2). 6. Aortic valve regurgitation (AR) \> +2 on a 4-grade scale using transthoracic echocardiography. 7. Femoral access site incompatibility that precludes placement of either the Treatment or Control device. 8. Patient on dialysis. 9. Known or suspected coagulopathy OR abnormal coagulation parameters. 10. Known allergy, sensitivity or intolerance to nickel. 11. Infection of the proposed procedural access site; OR suspected systemic active infection, including any fever or known active COVID-19 infection. 12. Allergy, sensitivity or intolerance to heparin, or contrast media, including known heparin-induced thrombocytopenia (HIT). 13. Any non-cardiac condition with a life expectancy \< 12 months. 14. 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). 15. Pregnancy or breast-feeding. 16. 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. 17. Subject belongs to a vulnerable population.

Conditions

High-Risk Percutaneous Coronary Intervention (High-risk PCI)

Locations

Banner-University Medical Center — Phoenix, Arizona, United States
HonorHealth Scottsdale Shea Medical Center/HonorHealth Deer Valley Medical Center — Scottsdale, Arizona, United States
UC San Diego Medical Center — La Jolla, California, United States
University of California at San Francisco Medical Center/Zuckerberg San Francisco General — San Francisco, California, United States
Tampa General/USF — Tampa, Florida, United States
Emory University Hospital / Emory University Hospital Midtown/ Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
Wellstar Health System — Marietta, Georgia, United States
University of Illinois at Chicago — Chicago, Illinois, United States
University of Chicago Medical Center — Chicago, Illinois, United States
St. Elizabeth Healthcare — Edgewood, Kentucky, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Brigham & Women's Hospital — Boston, Massachusetts, United States
Boston Medical Center — Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
UMass Memorial Medical Center — Worcester, Massachusetts, United States
Henry Ford Health — Detroit, Michigan, United States
Minneapolis Heart Institute — Minneapolis, Minnesota, United States
St. Luke's Hospital of Kansas City — Kansas City, Missouri, United States
Atlantic Health System — Morristown, New Jersey, United States
Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
Maimonides Health — Brooklyn, New York, United States
Buffalo General Medical Center — Buffalo, New York, United States
Northwell Health — Manhasset, New York, United States
NYU Langone/Bellevue/Long Island — New York, New York, United States
Mount Sinai — New York, New York, United States
Columbia University Medical Center/NYPH — New York, New York, United States
Weill Cornell Medical Center — New York, New York, United States
Mercy Health — Cincinnati, Ohio, United States
Kaiser Permanente — Clackamas, Oregon, United States
TriStar Centennial Medical Center — Nashville, Tennessee, United States
Inova Schar Heart & Vascular — Falls Church, Virginia, United States
Swedish Cherry Hill — Seattle, Washington, United States
Advocate Aurora Health Research Institute- St. Luke's Medical Center — Milwaukee, Wisconsin, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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