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ELEVATE High-Risk PCI Pivotal Study

Magenta Medical Ltd. · NCT07001332

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–88 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
290
US sites recruiting
33
Study start
July 25, 2025
Record last updated
October 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Elevate; Impella

Conditions: High-Risk Percutaneous Coronary Intervention (High-risk PCI)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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).
  • Baseline (uncorrected) hemoglobin >10.0 g/dl as long as an active source of blood loss has been reasonably excluded.
  • 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).
  • Aortic valve regurgitation (AR) > +2 on a 4-grade scale using 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.

Recruiting US locations

  • Banner-University Medical Center

    Phoenix, AZ 85006

    Site contact: David G Rizik, MD · 602-448-4858 · David.Rizik@Bannerhealth.com

  • HonorHealth Scottsdale Shea Medical Center/HonorHealth Deer Valley Medical Center

    Scottsdale, AZ 85260

    Site contact: Taral Patel, MD · 480-882-7450 · tapatel@honorhealth.com

  • UC San Diego Medical Center

    La Jolla, CA 92093

    Site contact: Ehtisham Mahmud, MD · 858-657-8030 · emahmud@health.ucsd.edu

  • University of California at San Francisco Medical Center/Zuckerberg San Francisco General

    San Francisco, CA 94143

    Site contact: Krishan Soni, MD · 415-502-4243 · Krishan.Soni@ucsf.edu

  • Tampa General/USF

    Tampa, FL 33606

    Site contact: Hiram Bezerra, MD · 813-844-8287 · hbezerra@usf.edu

  • Emory University Hospital / Emory University Hospital Midtown/ Emory Saint Joseph's Hospital

    Atlanta, GA 30322

    Site contact: William Nicholson, MD · 717-817-7233 · wjnicho@emory.edu

  • Wellstar Health System

    Marietta, GA 30062

    Site contact: Salvatore Mannino, MD · 470-793-4042 · Salvatore.Mannino@Wellstar.org

  • University of Illinois at Chicago

    Chicago, IL 60612

    Site contact: Adhir R Shroff, MD · 312-996-9086 · Arshroff@uic.edu

  • University of Chicago Medical Center

    Chicago, IL 60637

    Site contact: Sandeep Nathan, MD · 773-702-2697 · snathan@bsd.uchicago.edu

  • St. Elizabeth Healthcare

    Edgewood, KY 41017

    Site contact: Mohanjit (Mohan) Brar, MD · 859-287-3045 · mohan.brar@stelizabeth.com

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Suzanne J Baron, MD · 617-643-9617 · sbaron@mgb.org

  • Brigham & Women's Hospital

    Boston, MA 02115

    Site contact: Ajar Kochar, MD · 857-307-4000 · akochar@bwh.harvard.edu

  • Boston Medical Center

    Boston, MA 02118

    Site contact: Nir Ayalon, MD · 617-638-8716 · Nir.ayalon@bmc.org

  • Beth Israel Deaconess Medical Center

    Boston, MA 02215

    Site contact: Robert Yeh, MD · 617-632-8800 · Ryeh@bidmc.harvard.edu

  • UMass Memorial Medical Center

    Worcester, MA 01605

    Site contact: Nikolaos Kakouros, MD · 774-455-4832 · Nikolaos.Kakouros@umassmemorial.org

  • Henry Ford Health

    Detroit, MI 48202

    Site contact: Mir Basir, DO · 313-916-0015 · MBASIR1@hfhs.org

  • Minneapolis Heart Institute

    Minneapolis, MN 55407

    Site contact: Emmanouil Brilakis, MD · 612-863-0243 · Emmanouil.brilakis@allina.com

  • St. Luke's Hospital of Kansas City

    Kansas City, MO 64111

    Site contact: Dany Jacob, MD · 816-932-5724 · djacob@saint-lukes.org

  • Atlantic Health System

    Morristown, NJ 07960

    Site contact: Saad Ahmad, MD · 973-971-6620 · saad.ahmad@atlantichealth.org

  • Robert Wood Johnson University Hospital

    New Brunswick, NJ 08901

    Site contact: Tudor Vagaonescu, MD · 732-418-8189 · vagaontd@rwjms.rutgers.edu

  • Maimonides Health

    Brooklyn, NY 11219

    Site contact: Robert Frankel, MD · 718-283-7064 · Rfrankel@maimo.org

  • Buffalo General Medical Center

    Buffalo, NY 14203

    Site contact: Vijay Iyer, MD · 716-881-8299 · vsiyer@buffalo.edu

  • Northwell Health

    Manhasset, NY 11030

    Site contact: Perwaiz Meraj, MD · 516-600-1480 · Pmeraj@Northwell.edu

  • NYU Langone/Bellevue/Long Island

    New York, NY 10023

    Site contact: Louai Razzouk, MD · 212-263-5656 · Louai.Razzouk@nyulangone.org

  • Mount Sinai

    New York, NY 10029

    Site contact: Amit Hooda, MD · 212-241-9687 · Amit.hooda@mountsinai.org

  • Columbia University Medical Center/NYPH

    New York, NY 10032

    Site contact: Margaret McEntegart, MD · 212-305-7060 · mbm2179@cumc.columbia.edu

  • Weill Cornell Medical Center

    New York, NY 10065

    Site contact: Jaikirshan Khatri, MD · 212-746-4617 · Jak4033@med.cornell.edu

  • Mercy Health

    Cincinnati, OH 45211

    Site contact: Adam Raskin, MD · 513-215-9200 · ARaskin@mercy.com

  • Kaiser Permanente

    Clackamas, OR 97015

    Site contact: Jeffrey A Marbach, MD · 503-813-2000 · Jeffrey.A.Marbach@kp.org

  • TriStar Centennial Medical Center

    Nashville, TN 37203

    Site contact: Brian Jefferson, MD · 615-981-2414 · brian.jefferson@hcahealthcare.com

  • Inova Schar Heart & Vascular

    Falls Church, VA 22042

    Site contact: Shashank Sinha, MD · 703-776-2828 · shashank.sinha@inova.org

  • Swedish Cherry Hill

    Seattle, WA 98122

    Site contact: Christopher Brown, MD · 206-320-3919 · Christopher.Brown@Swedish.org

  • Advocate Aurora Health Research Institute- St. Luke's Medical Center

    Milwaukee, WI 53215

    Site contact: Louie Kostopoulos, MD · 414-649-3546 · Louie.Kostopoulos@aah.org

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ELEVATE High-Risk PCI Pivotal Study (NCT07001332) | Bored Studies