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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• Banner-University Medical Center
  Phoenix, Arizona, United States Recruiting
• HonorHealth Scottsdale Shea Medical Center/HonorHealth Deer Valley Medical Center
  Scottsdale, Arizona, United States Recruiting
• UC San Diego Medical Center
  La Jolla, California, United States Recruiting
• University of California at San Francisco Medical Center/Zuckerberg San Francisco General
  San Francisco, California, United States Recruiting
• Tampa General/USF
  Tampa, Florida, United States Recruiting
• Emory University Hospital / Emory University Hospital Midtown/ Emory Saint Joseph's Hospital
  Atlanta, Georgia, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using a percutaneous left ventricular assist device to support high-risk PCI in complex coronary patients

  This trial tests whether the VADLINK percutaneous left ventricular assist device works better and is as safe as VA‑ECMO for people with very weak hearts who need high‑risk PCI.

  Recruiting Suzhou Hengruihongyuan Medical Technology Co. LTD · Beijing, Beijing Municipality and 14 other locations · NCT07053618

• Magenta Elevate™ device for cardiogenic shock

  This trial tries the Magenta Elevate™ device to see if it can safely support people with cardiogenic shock caused by left ventricular failure.

  Recruiting at 8 sites Magenta Medical Ltd. · Tbilisi and 7 other locations · NCT07293923

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.