An interventional study of Elevate and Impella in High-Risk Percutaneous Coronary Intervention (High-risk PCI), sponsored by Magenta Medical Ltd.. Recruiting at 33 sites in United States. Open to participants aged 18 Years to 88 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Magenta Medical Ltd. · Not applicable, Interventional, and Treatment
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).
The Elevate™ percutaneous Left Ventricular Assist Device System is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (HR-PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease. Use of the Elevate™ System in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions.
Magenta Medical Ltd. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects receiving the Elevate System
Device: Elevate
Subjects receiving the Impella System
Device: Impella
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.
A composite of the incidence of major safety and effectiveness parameters.
A composite of the incidence of: 1. Major Adverse Cardiac and Cerebrovascular Events (MACCE): Death, Myocardial Infarction, Stroke or Transient Ischemic Attack, Unplanned Repeat Revascularization; 2. Major intra-procedural hemodynamic events on Mechanical Circulatory Support: Severe Hypotension, Cardio-Pulmonary Resuscitation or Cardioversion; 3. Major Mechanical Circulatory Support-related access site complications: Vascular Injury Requiring Intervention or Access Site Bleeding.
Time frame: 30 days
Major Hemolysis during index hospitalization
Incidence of Major Hemolysis
Time frame: Perioperative/Periprocedural
Incidence of Bleeding Academic Research Consortium (BARC) Type 3 or Type 5 bleeding events related to the index percutaneous coronary intervention.
The incidence of bleeding events related to the index percutaneous coronary intervention meeting the definition of Bleeding Academic Research Consortium (BARC) Type 3 or Type 5 bleeding.
Time frame: Perioperative/Periprocedural
Length of hospital stay
Length of hospital stay across all enrolled patients
Time frame: Perioperative/Periprocedural
Length of ICU/CCU stay
Length of ICU/CCU stay across all enrolled patients
Time frame: Perioperative/Periprocedural
Plan to share: No
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Magenta Medical Ltd.