ELEVATE High-Risk PCI Pivotal Study (ELEVATE III)

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: High-Risk Percutaneous Coronary Intervention (High-risk PCI)
• Intervention / Treatment: Device: Elevate; Device: Impella

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

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Recruiting
      • HonorHealth Scottsdale Shea Medical Center
      • Principal Investigator: Taral Patel, MD
      • Contact: Taral Patel, MD; Phone Number: 480-882-7450; Email: tapatel@honorhealth.com
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California at San Francisco Medical Center
      • Principal Investigator: Krishan Soni, MD
      • Contact: Krishan Soni, MD; Phone Number: 415-502-4243; Email: Krishan.Soni@ucsf.edu
  • Florida
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Tampa General/USF
      • Contact: Hiram Bezerra, MD; Phone Number: 813-844-8287; Email: hbezerra@usf.edu
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University Hospital / Emory University Hospital Midtown
      • Principal Investigator: William Nicholson, MD
      • Contact: William Nicholson, MD; Phone Number: 717-817-7233; Email: wjnicho@emory.edu
    • Marietta, Georgia, United States, 30062
      • Recruiting
      • Wellstar Health System
      • Contact: Salvatore Mannino, MD; Phone Number: 470-793-4042; Email: Salvatore.Mannino@Wellstar.org
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medical Center
      • Principal Investigator: Sandeep Nathan, MD
      • Contact: Sandeep Nathan, MD; Phone Number: 773-702-2697; Email: snathan@bsd.uchicago.edu
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Recruiting
      • St. Elizabeth Healthcare
      • Contact: Mohanjit (Mohan) Brar, MD; Phone Number: 859-287-3045; Email: mohan.brar@stelizabeth.com
  • 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: Robert Yeh, MD; Phone Number: 617-632-8800; Email: Ryeh@bidmc.harvard.edu
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center
      • Contact: Nir Ayalon, MD; Phone Number: 617-638-8716; Email: Nir.ayalon@bmc.org
      • Principal Investigator: Nir Ayalon, MD
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham & Women's Hospital
      • Contact: Ajar Kochar, MD; Phone Number: 857-307-4000; Email: akochar@bwh.harvard.edu
      • Principal Investigator: Ajar Kochar, MD
    • Worcester, Massachusetts, United States, 01605
      • Recruiting
      • UMass Memorial Medical Center
      • Principal Investigator: Nikolaos Kakouros, MD
      • Contact: Nikolaos Kakouros, MD; Phone Number: 774-455-4832; Email: Nikolaos.Kakouros@umassmemorial.org
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health
      • Contact: Mir Basir, DO; Phone Number: 313-916-0015; Email: MBASIR1@hfhs.org
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Minneapolis Heart Institute
      • Contact: Emmanouil Brilakis, MD; Phone Number: 612-863-0243; Email: Emmanouil.brilakis@allina.com
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • St. Luke's Hospital of Kansas City
      • Principal Investigator: Dany Jacob, MD
      • Contact: Dany Jacob, MD; Phone Number: 816-932-5724; Email: djacob@saint-lukes.org
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Recruiting
      • Atlantic Health System
      • Principal Investigator: Saad Ahmad, MD
      • Contact: Saad Ahmad, MD; Phone Number: 973-971-6620; Email: saad.ahmad@atlantichealth.org
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Robert Wood Johnson University Hospital
      • Contact: Tudor Vagaonescu, MD; Phone Number: 732-418-8189; Email: vagaontd@rwjms.rutgers.edu
      • Principal Investigator: Tudor Vagaonescu, MD
  • New York
    • Brooklyn, New York, United States, 11219
      • Recruiting
      • Maimonides Health
      • Contact: Robert Frankel, MD; Phone Number: 718-283-7064; Email: Rfrankel@maimo.org
    • Buffalo, New York, United States, 14203
      • Recruiting
      • Buffalo General Medical Center
      • Principal Investigator: Vijay Iyer, MD
      • Contact: Vijay Iyer, MD; Phone Number: 716-881-8299; Email: vsiyer@buffalo.edu
    • Manhasset, New York, United States, 11030
      • Recruiting
      • Northwell Health
      • Contact: Perwaiz Meraj, MD; Phone Number: 516-600-1480; Email: Pmeraj@Northwell.edu
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center/NYPH
      • Contact: Margaret McEntegart, MD; Phone Number: 212-305-7060; Email: mbm2179@cumc.columbia.edu
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai
      • Contact: Amit Hooda, MD; Phone Number: 212-241-9687; Email: Amit.hooda@mountsinai.org
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medical Center
      • Contact: Jaikirshan Khatri, MD; Phone Number: 212-746-4617; Email: Jak4033@med.cornell.edu
    • New York, New York, United States, 10023
      • Recruiting
      • NYU Langone/Bellevue/Long Island
      • Principal Investigator: Dimitrios Bliagos, MD
      • Contact: Louai Razzouk, MD; Phone Number: 212-263-5656; Email: Louai.Razzouk@nyulangone.org
  • Ohio
    • Cincinnati, Ohio, United States, 45211
      • Recruiting
      • Mercy Health
      • Principal Investigator: Adam Raskin, MD
      • Contact: Adam Raskin, MD; Phone Number: 513-215-9200; Email: ARaskin@mercy.com
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • TriStar Centennial Medical Center
      • Principal Investigator: Brian Jefferson, MD
      • Contact: Brian Jefferson, MD; Phone Number: 615-981-2414; Email: brian.jefferson@hcahealthcare.com
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Recruiting
      • Inova Schar Heart & Vascular
      • Contact: Shashank Sinha, MD; Phone Number: 703-776-2828; Email: shashank.sinha@inova.org
      • Principal Investigator: Shashank Sinha, MD
  • Washington
    • Seattle, Washington, United States, 98122
      • Recruiting
      • Swedish Cherry Hill
      • Principal Investigator: Christopher Brown, MD
      • Contact: Christopher Brown, MD; Phone Number: 206-320-3919; Email: Christopher.Brown@Swedish.org
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Recruiting
      • Advocate Aurora Health Research Institute- St. Luke's Medical Center
      • Contact: Louie Kostopoulos, MD; Phone Number: 414-649-3546; Email: Louie.Kostopoulos@aah.org

Participation Criteria

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. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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.	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	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.	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	Length of hospital stay across all enrolled patients	Perioperative/Periprocedural
Length of ICU/CCU stay	Length of ICU/CCU stay across all enrolled patients	Perioperative/Periprocedural

Collaborators and Investigators

• Sponsor: Magenta Medical Ltd.

Study record dates

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): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 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