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High-Risk Percutaneous Coronary Intervention (High-risk PCI)ELEVATE IIINCT07001332

ELEVATE High-Risk PCI Pivotal Study

A study testing Elevate and Impella in people with High-Risk Percutaneous Coronary Intervention (High-risk PCI), run by Magenta Medical Ltd. at 33 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 88 years
What is being tested?
Elevate and Impella
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
33 sitesUnited States
Study dates
25 Jul 2025to 16 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 88 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

33 sites in 1 country. Contact the study team or a site near you to ask about taking part.

33 sites in 1 country

United States33 sites, 33 recruiting

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

    Atlanta, Georgia, 30322

    William Nicholson, MD, 717-817-7233, wjnicho@emory.edu

    William Nicholson, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Suzanne J Baron, MD, 617-643-9617, sbaron@mgb.org

    Recruiting

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

    Ajar Kochar, MD, 857-307-4000, akochar@bwh.harvard.edu

    Ajar Kochar, MD

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Nir Ayalon, MD, 617-638-8716, Nir.ayalon@bmc.org

    Nir Ayalon, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Robert Yeh, MD, 617-632-8800, Ryeh@bidmc.harvard.edu

    Robert Yeh, MD

    Recruiting

  • Maimonides Health

    Brooklyn, New York, 11219

    Robert Frankel, MD, 718-283-7064, Rfrankel@maimo.org

    Recruiting

  • Buffalo General Medical Center

    Buffalo, New York, 14203

    Vijay Iyer, MD, 716-881-8299, vsiyer@buffalo.edu

    Vijay Iyer, MD

    Recruiting

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

    Adhir R Shroff, MD, 312-996-9086, Arshroff@uic.edu

    Adhir R Shroff, MD

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Sandeep Nathan, MD, 773-702-2697, snathan@bsd.uchicago.edu

    Sandeep Nathan, MD

    Recruiting

  • Mercy Health

    Cincinnati, Ohio, 45211

    Adam Raskin, MD, 513-215-9200, ARaskin@mercy.com

    Adam Raskin, MD

    Recruiting

  • Kaiser Permanente

    Clackamas, Oregon, 97015

    Jeffrey A Marbach, MD, 503-813-2000, Jeffrey.A.Marbach@kp.org

    Jeffrey A Marbach, MD

    Recruiting

  • Henry Ford Health

    Detroit, Michigan, 48202

    Mir Basir, DO, 313-916-0015, MBASIR1@hfhs.org

    Recruiting

  • St. Elizabeth Healthcare

    Edgewood, Kentucky, 41017

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

    Recruiting

  • Inova Schar Heart & Vascular

    Falls Church, Virginia, 22042

    Shashank Sinha, MD, 703-776-2828, shashank.sinha@inova.org

    Shashank Sinha, MD

    Recruiting

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

    Dany Jacob, MD, 816-932-5724, djacob@saint-lukes.org

    Dany Jacob, MD

    Recruiting

  • UC San Diego Medical Center

    La Jolla, California, 92093

    Ehtisham Mahmud, MD, 858-657-8030, emahmud@health.ucsd.edu

    Ehtisham Mahmud, MD

    Recruiting

  • Northwell Health

    Manhasset, New York, 11030

    Perwaiz Meraj, MD, 516-600-1480, Pmeraj@Northwell.edu

    Recruiting

  • Wellstar Health System

    Marietta, Georgia, 30062

    Salvatore Mannino, MD, 470-793-4042, Salvatore.Mannino@Wellstar.org

    Recruiting

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

    Milwaukee, Wisconsin, 53215

    Louie Kostopoulos, MD, 414-649-3546, Louie.Kostopoulos@aah.org

    Recruiting

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

    Emmanouil Brilakis, MD, 612-863-0243, Emmanouil.brilakis@allina.com

    Recruiting

  • Atlantic Health System

    Morristown, New Jersey, 07960

    Saad Ahmad, MD, 973-971-6620, saad.ahmad@atlantichealth.org

    Saad Ahmad, MD

    Recruiting

  • TriStar Centennial Medical Center

    Nashville, Tennessee, 37203

    Brian Jefferson, MD, 615-981-2414, brian.jefferson@hcahealthcare.com

    Brian Jefferson, MD

    Recruiting

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901

    Tudor Vagaonescu, MD, 732-418-8189, vagaontd@rwjms.rutgers.edu

    Tudor Vagaonescu, MD

    Recruiting

  • NYU Langone/Bellevue/Long Island

    New York, New York, 10023

    Louai Razzouk, MD, 212-263-5656, Louai.Razzouk@nyulangone.org

    Dimitrios Bliagos, MD

    Recruiting

  • Mount Sinai

    New York, New York, 10029

    Amit Hooda, MD, 212-241-9687, Amit.hooda@mountsinai.org

    Recruiting

  • Columbia University Medical Center/NYPH

    New York, New York, 10032

    Margaret McEntegart, MD, 212-305-7060, mbm2179@cumc.columbia.edu

    Recruiting

  • Weill Cornell Medical Center

    New York, New York, 10065

    Jaikirshan Khatri, MD, 212-746-4617, Jak4033@med.cornell.edu

    Recruiting

  • Banner-University Medical Center

    Phoenix, Arizona, 85006

    David G Rizik, MD, 602-448-4858, David.Rizik@Bannerhealth.com

    David G Rizik, MD

    Recruiting

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

    San Francisco, California, 94143

    Krishan Soni, MD, 415-502-4243, Krishan.Soni@ucsf.edu

    Krishan Soni, MD

    Recruiting

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

    Scottsdale, Arizona, 85260

    Taral Patel, MD, 480-882-7450, tapatel@honorhealth.com

    Taral Patel, MD

    Recruiting

  • Swedish Cherry Hill

    Seattle, Washington, 98122

    Christopher Brown, MD, 206-320-3919, Christopher.Brown@Swedish.org

    Christopher Brown, MD

    Recruiting

  • Tampa General/USF

    Tampa, Florida, 33606

    Hiram Bezerra, MD, 813-844-8287, hbezerra@usf.edu

    Recruiting

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01605

    Nikolaos Kakouros, MD, 774-455-4832, Nikolaos.Kakouros@umassmemorial.org

    Nikolaos Kakouros, MD

    Recruiting

Other trials in United States

About this study

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).

Read the detailed description

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.

Being tested
Elevate, Impella

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElevateDevice

    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.

  • ImpellaDevice

    Subjects will receive an Impella prior to their high-risk percutaneous intervention.

Study groups in NCT07001332
Study groupRoleWhat they receive
ElevateExperimentalSubjects receiving the Elevate System
Receives: Device: Elevate
ImpellaActive comparatorSubjects receiving the Impella System
Receives: Device: Impella

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days

Secondary outcomes (4)

  1. Major Hemolysis during index hospitalization

    Incidence of Major Hemolysis

    Measured: Perioperative/Periprocedural

  2. 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.

    Measured: Perioperative/Periprocedural

  3. Length of hospital stay

    Length of hospital stay across all enrolled patients

    Measured: Perioperative/Periprocedural

  4. Length of ICU/CCU stay

    Length of ICU/CCU stay across all enrolled patients

    Measured: Perioperative/Periprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2025
  2. Study start25 Jul 2025
  3. Primary completion16 Mar 2027 (estimated)
  4. Study completion16 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, multi-center, open-label, interventional, randomized, and controlled study with an active control group.
Masking
None (open label)
Enrolment
290 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07001332
Sponsor's protocol ID
DRD-0001723
Acronym
ELEVATE III
Status last verified
Oct 2026
First submitted
7 May 2025
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Elevate and Impella in people with High-Risk Percutaneous Coronary Intervention (High-risk PCI), run by Magenta Medical Ltd. at 33 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A composite of the incidence of major safety and effectiveness parameters. (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07001332.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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