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ELEVATE High-Risk PCI Pivotal Study | Clinical Trials | Clareo Health

RECRUITINGNA

ELEVATE High-Risk PCI Pivotal Study

NCT07001332•Magenta Medical Ltd.

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).

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.

Eligibility

Age

18 - 88 years

Sex

ALL

Healthy Volunteers

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.
+7 more criteria

Locations (28)

HonorHealth Scottsdale Shea Medical Center

Scottsdale, Arizona, United States

University of California at San Francisco Medical Center

San Francisco, California, United States

Tampa General/USF

Tampa, Florida, United States

Wellstar Health System

Marietta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

St. Elizabeth Healthcare

Edgewood, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Key Dates

Start Date

July 25, 2025

Primary Completion Date

March 16, 2027

Completion Date

September 16, 2027

Last Updated

March 17, 2026

Enrollment

290

ESTIMATED participants

Conditions

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

Interventions

Elevate

DEVICE

Impella

DEVICE

Interventional Left Ventricular Assist System for PCI in CHIP Patients

NCT07053618

High-Risk Percutaneous Coronary Intervention (High-risk PCI)Left Ventricular Assist Devices

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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