NCT07001332 · Magenta Medical Ltd.
ELEVATE High-Risk PCI Pivotal Study
(ELEVATE III)
What this study is about
The ELEVATE III Pivotal Study is a forward-looking, multi-center, where both patients and doctors know the treatment given, interventional, randomly assigned, controlled study with an active control group.
View original scientific 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
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.
Primary outcome measures
A composite of the incidence of major safety and effectiveness parameters.
Time frame: 30 days
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- Phoenix, Arizona
- Scottsdale, Arizona
- La Jolla, California
- San Francisco, California
- Tampa, Florida
- Atlanta, Georgia
- Marietta, Georgia
- Chicago, Illinois
- Edgewood, Kentucky
- Boston, Massachusetts
- Worcester, Massachusetts
- Detroit, Michigan
And 14 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2026 · Source of record for eligibility and locations