ELEVATE High-Risk PCI Pivotal Study (ELEVATE III)

September 14, 2026 updated by: Magenta Medical Ltd.
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Banner-University Medical Center
        • Principal Investigator:
          • David G Rizik, MD
        • Contact:
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • HonorHealth Scottsdale Shea Medical Center/HonorHealth Deer Valley Medical Center
        • Principal Investigator:
          • Taral Patel, MD
        • Contact:
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Medical Center
        • Principal Investigator:
          • Ehtisham Mahmud, MD
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California at San Francisco Medical Center/Zuckerberg San Francisco General
        • Principal Investigator:
          • Krishan Soni, MD
        • Contact:
    • Florida
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General/USF
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital / Emory University Hospital Midtown/ Emory Saint Joseph's Hospital
        • Principal Investigator:
          • William Nicholson, MD
        • Contact:
      • Marietta, Georgia, United States, 30062
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University Of Chicago Medical Center
        • Principal Investigator:
          • Sandeep Nathan, MD
        • Contact:
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois at Chicago
        • Contact:
        • Principal Investigator:
          • Adhir R Shroff, MD
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Recruiting
        • St. Elizabeth Healthcare
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Suzanne J Baron, MD
          • Phone Number: 617-643-9617
          • Email: sbaron@mgb.org
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Robert Yeh, MD
        • Contact:
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Contact:
        • Principal Investigator:
          • Nir Ayalon, MD
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham & Women's Hospital
        • Contact:
        • Principal Investigator:
          • Ajar Kochar, MD
      • Worcester, Massachusetts, United States, 01605
        • Recruiting
        • UMass Memorial Medical Center
        • Principal Investigator:
          • Nikolaos Kakouros, MD
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • St. Luke's Hospital of Kansas City
        • Principal Investigator:
          • Dany Jacob, MD
        • Contact:
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Atlantic Health System
        • Principal Investigator:
          • Saad Ahmad, MD
        • Contact:
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Robert Wood Johnson University Hospital
        • Contact:
        • Principal Investigator:
          • Tudor Vagaonescu, MD
    • New York
      • Brooklyn, New York, United States, 11219
        • Recruiting
        • Maimonides Health
        • Contact:
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Buffalo General Medical Center
        • Principal Investigator:
          • Vijay Iyer, MD
        • Contact:
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell Health
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center/NYPH
        • Contact:
      • New York, New York, United States, 10029
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medical Center
        • Contact:
      • New York, New York, United States, 10023
        • Recruiting
        • NYU Langone/Bellevue/Long Island
        • Principal Investigator:
          • Dimitrios Bliagos, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45211
        • Recruiting
        • Mercy Health
        • Principal Investigator:
          • Adam Raskin, MD
        • Contact:
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Kaiser Permanente
        • Contact:
        • Principal Investigator:
          • Jeffrey A Marbach, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • TriStar Centennial Medical Center
        • Principal Investigator:
          • Brian Jefferson, MD
        • Contact:
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Schar Heart & Vascular
        • Contact:
        • Principal Investigator:
          • Shashank Sinha, MD
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Cherry Hill
        • Principal Investigator:
          • Christopher Brown, MD
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Advocate Aurora Health Research Institute- St. Luke's Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elevate
Subjects receiving the Elevate System
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.
Active Comparator: Impella
Subjects receiving the Impella System
Device: Impella
Subjects will receive an Impella prior to their high-risk percutaneous intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Hemolysis during index hospitalization
Time Frame: Perioperative/Periprocedural
Incidence of Major Hemolysis
Perioperative/Periprocedural
Incidence of Bleeding Academic Research Consortium (BARC) Type 3 or Type 5 bleeding events related to the index percutaneous coronary intervention.
Time Frame: Perioperative/Periprocedural
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.
Perioperative/Periprocedural
Length of hospital stay
Time Frame: Perioperative/Periprocedural
Length of hospital stay across all enrolled patients
Perioperative/Periprocedural
Length of ICU/CCU stay
Time Frame: Perioperative/Periprocedural
Length of ICU/CCU stay across all enrolled patients
Perioperative/Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Magenta Medical Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2025

Primary Completion (Estimated)

March 16, 2027

Study Completion (Estimated)

September 16, 2027

Study Registration Dates

First Submitted

May 7, 2025

First Submitted That Met QC Criteria

May 23, 2025

First Posted (Actual)

June 3, 2025

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • DRD-0001723

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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