ELEVATE High-Risk PCI Pivotal Study

NCT07001332 | Recruiting DMC FDA Device

• 1 other identifier: DRD-0001723
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 29

Brief 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 coronary interventions (HR-PCI).

Conditions

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

Outcome Measures

Primary Outcomes (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.

  30 days

Secondary Outcomes (4)

• Major Hemolysis during index hospitalization

  Perioperative/Periprocedural

• Incidence of Bleeding Academic Research Consortium (BARC) Type 3 or Type 5 bleeding events related to the index percutaneous coronary intervention.

  Perioperative/Periprocedural

• Length of hospital stay

  Perioperative/Periprocedural

• Length of ICU/CCU stay

  Perioperative/Periprocedural

Study Arms (2)

Elevate

EXPERIMENTAL

Subjects receiving the Elevate System

Device: Elevate

Impella

ACTIVE COMPARATOR

Subjects receiving the Impella System

Device: Impella

Interventions

Elevate DEVICE

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.

Elevate

Impella DEVICE

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

Impella

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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).
• ≥ Moderate aortic valve regurgitation (≥ 2+ on a 4-grade scale by 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.

Sponsors & Collaborators

• Magenta Medical Ltd.: lead

Study Sites (29)

HonorHealth Scottsdale Shea Medical Center

Scottsdale, Arizona, 85260, United States

RECRUITING

University of California at San Francisco Medical Center

San Francisco, California, 94143, United States

RECRUITING

Tampa General/USF

Tampa, Florida, 33606, United States

RECRUITING

Emory University Hospital / Emory University Hospital Midtown

Atlanta, Georgia, 30322, United States

RECRUITING

Wellstar Health System

Marietta, Georgia, 30062, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

St. Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

UMass Memorial Medical Center

Worcester, Massachusetts, 01605, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

RECRUITING

St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

RECRUITING

Atlantic Health System

Morristown, New Jersey, 07960, United States

RECRUITING

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

RECRUITING

Maimonides Health

Brooklyn, New York, 11219, United States

RECRUITING

Buffalo General Medical Center

Buffalo, New York, 14203, United States

RECRUITING

Northwell Health

Manhasset, New York, 11030, United States

RECRUITING

NYU Langone/Bellevue/Long Island

New York, New York, 10023, United States

RECRUITING

Mount Sinai

New York, New York, 10029, United States

RECRUITING

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

RECRUITING

Weill Cornell Medical Center

New York, New York, 10065, United States

RECRUITING

Mercy Health

Cincinnati, Ohio, 45211, United States

RECRUITING

TriStar Centennial Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

Inova Schar Heart & Vascular

Falls Church, Virginia, 22042, United States

RECRUITING

Swedish Cherry Hill

Seattle, Washington, 98122, United States

RECRUITING

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

Milwaukee, Wisconsin, 53215, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, multi-center, open-label, interventional, randomized, and controlled study with an active control group.

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: June 3, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): March 16, 2027
• Study Completion (Estimated): September 16, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (29)