Magenta Elevate™ EFS in High-Risk PCI Patients

Early Feasibility Study (EFS) of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients Undergoing Non-emergent, High-risk Percutaneous Coronary Interventions

The Elevate™ EFS study is designed to evaluate the safety and feasibility of the Magenta Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary interventions.

Study Overview

• Status: Completed
• Conditions: High-risk Percutaneous Coronary Intervention
• Intervention / Treatment: Device: The Elevate™ System

Detailed Description

The Elevate™ EFS is planned as a prospective, single-arm, interventional multi-center study enrolling up to 20 subjects.

The Magenta Elevate™ Pump is a catheter-mounted, self-expanding and retrievable pump, designed to unload the left ventricle by actively transporting blood from the left ventricle into the ascending aorta.

The Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10032
      • New York-Presbyterian Hospital/Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Non-emergent, percutaneous coronary intervention is planned in at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis).

2. Ejection fraction of ≤ 50% and at least one of the following:

   1. Intervention on an unprotected left main coronary artery
   2. Intervention on a last patent coronary conduit
   3. Three-vessel disease (in case of left coronary artery dominance, the combination of a left anterior descending artery (LAD) lesion and a proximal left circumflex artery (LCX) lesion qualifies as three-vessel disease).
3. A heart team that includes a cardiac surgeon has determined that high-risk PCI is the appropriate therapeutic option.
4. Subject signed informed consent.

Exclusion Criteria:

1. Subject age < 18 or ≥ 85 years.
2. Cardiogenic shock (systolic blood pressure < 90 mmHg with evidence of end organ hypoperfusion, such as cool extremities or urine < 30 mL/hour); acutely decompensated pre-existing chronic heart failure; any use of inotropic or vasopressor in the previous 48 hours; or any use of mechanical circulatory support or an extracorporeal membrane oxygenation device within 14 days.
3. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis
4. Evidence of left ventricular thrombus.
5. Previous aortic valve replacement or repair or a heart-constrictive device.
6. Aortic stenosis
7. Aortic regurgitation (≥ 2+ on a 4-grade scale by Transthoracic Echocardiography).
8. Aortic pathology, such as aortic aneurysms, dissection, extreme tortuosity, calcifications, or prior aortic surgery, that could pose undue additional risk to the placement of a pLVAD device.
9. Left ventricle rupture.
10. Cardiac tamponade.
11. Subject is scheduled for a staged PCI within 90 days of the index procedure
12. Subject has any condition or scheduled surgery that will require discontinuation of the antiplatelet and/or anticoagulant therapy within 90 days of the index procedure.
13. Chronic renal dysfunction (eGFR <30 mL/min/1.73 m²) and patients requiring renal replacement therapy with dialysis.
14. Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000 or spontaneous INR ≥ 1.5 or known fibrinogen ≤ 1.5 g/L).
15. Infection of the proposed procedural access site or suspected systemic active infection, including any fever.
16. Active COVID-19 infection.
17. Stroke or transient ischemic attack within 6 months of enrollment.
18. 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).
19. Female subjects who are pregnant or breast-feeding.
20. Any non-cardiac condition with a life expectancy <24 months
21. Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to provide written informed consent and/or to comply with study procedures.
22. Subject belongs to a vulnerable population defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of providing informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HR-PCI patients; Patients undergoing non-emergent, high-risk percutaneous coronary interventions	Device: The Elevate™ System; The Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Major Device-Related Adverse Events (MDRAE)	The rate of Elevate™ related Serious Adverse Events	From device delivery through device removal (up to 6 hours)
Rate of successful initiation and maintenance of hemodynamic support without Severe Hypotension	Rate of successful initiation and maintenance of Elevate™ hemodynamic support without Severe Hypotension	From device delivery through device removal (up to 6 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Elevate™ Technical Success	The rate of complete Elevate™ Pump delivery procedures, including operation of the Pump without Device Malfunction and successful retrieval of the Pump	From device delivery through device removal (up to 6 hours)
Rate of Elevate™ Procedural Success	The rate of Elevate™ Technical Success without Severe Hypotension	From device delivery through device removal (up to 6 hours)
Rate of Major Device-Related Adverse Events (MDRAE)	The rate of Elevate™ related Serious Adverse Events	From device removal through hospital discharge (assessed up to 30 days)
Rate of Major Device-Related Adverse Events (MDRAE)	The rate of Elevate™ related Serious Adverse Events	From hospital discharge through 30-days post device removal

Collaborators and Investigators

• Sponsor: Magenta Medical Ltd.
• Investigators: Study Director: Zohar Bronshtine, Magenta Medical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): January 2, 2024

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: HRPCI; High-risk percutaneous coronary intervention; Circulatory support; Left ventricular unloading
• Other Study ID Numbers: DRD00417

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No