ELEVATE High-Risk PCI Pivotal Study
Magenta Medical Ltd.
290 participants
Jul 25, 2025
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria3
- 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.
Exclusion Criteria17
- 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.
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Interventions
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.
Subjects will receive an Impella prior to their high-risk percutaneous intervention.
Locations(28)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07001332