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ELEVATE High-Risk PCI Pivotal: short-term ventricular support during high-risk coronary procedures

ELEVATE High-Risk PCI Pivotal Study

Not applicable Interventional Magenta Medical Ltd. · NCT07001332

This study will test the Elevate short-term percutaneous left ventricular assist device in adults having planned high‑risk PCI to see if it prevents drops in blood pressure and other complications during the procedure.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment290 (estimated)
Ages18 Years to 88 Years
SexAll
SponsorMagenta Medical Ltd. Industry-sponsored
Locations29 sites (Scottsdale, Arizona and 28 other locations)
Trial IDNCT07001332 on ClinicalTrials.gov

What this trial studies

ELEVATE III is a prospective, multicenter, open-label, randomized, controlled trial comparing the Elevate percutaneous left ventricular assist device to an active control during non-emergent high‑risk PCI. Participants are hemodynamically stable adults with severe coronary disease selected by a heart team and randomized to receive Elevate support or an alternative device during the planned PCI with device support limited to ≤6 hours. The trial collects safety and efficacy outcomes related to intra-procedural hemodynamic stability, procedural success, and short-term complications. Study procedures occur at U.S. academic and regional centers with interventional cardiology and cardiac surgery support.

Who should consider this trial

Good fit: Ideal candidates are hemodynamically stable adults scheduled for non-emergent high‑risk PCI who have been approved by a heart team and meet the study's vascular access and safety criteria.

Not a fit: Patients in cardiogenic shock, with left ventricular thrombus, significant aortic valve disease, recent stroke/TIA, or who require stopping antiplatelet/anticoagulation within 90 days are excluded and unlikely to benefit from this device.

Why it matters

Potential benefit: If successful, the device could reduce intra-procedural drops in blood pressure and lower the risk of complications during high‑risk PCI, improving procedure safety.

How similar studies have performed: Percutaneous LV assist devices such as Impella have been used in prior observational and randomized studies with mixed results, so the concept has supporting but not definitive randomized evidence and this device is a newer entrant.

Eligibility criteria

Show full inclusion / exclusion 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. A heart team that includes an interventional cardiologist and cardiac surgeon has determined that HR- PCI is an appropriate therapeutic option.
3. 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. ≥ Moderate aortic valve regurgitation (≥ 2+ on a 4-grade scale by 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.

Where this trial is running

Scottsdale, Arizona and 28 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions High-Risk Percutaneous Coronary Intervention
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.