Magenta Elevate™ EFS in High-Risk PCI Patients

NCT05727059 | Completed FDA Device

• 1 other identifier: DRD00417
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

High-risk Percutaneous Coronary Intervention

Keywords

HRPCI; High-risk percutaneous coronary intervention; Circulatory support; Left ventricular unloading

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Rate of Elevate™ Technical Success

  From device delivery through device removal (up to 6 hours)

• Rate of Elevate™ Procedural Success

  From device delivery through device removal (up to 6 hours)

• Rate of Major Device-Related Adverse Events (MDRAE)

  From device removal through hospital discharge (assessed up to 30 days)

• Rate of Major Device-Related Adverse Events (MDRAE)

  From hospital discharge through 30-days post device removal

Study Arms (1)

HR-PCI patients

EXPERIMENTAL

Patients undergoing non-emergent, high-risk percutaneous coronary interventions

Device: The Elevate™ System

Interventions

The Elevate™ System DEVICE

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.

HR-PCI patients

Eligibility Criteria

• Age: 18 Years - 84 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 in at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis).
• Ejection fraction of ≤ 50% and at least one of the following:
• Intervention on an unprotected left main coronary artery
• Intervention on a last patent coronary conduit
• 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).
• A heart team that includes a cardiac surgeon has determined that high-risk PCI is the appropriate therapeutic option.
• Subject signed informed consent.

You may not qualify if:

• Subject age \< 18 or ≥ 85 years.
• 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.
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis
• Evidence of left ventricular thrombus.
• Previous aortic valve replacement or repair or a heart-constrictive device.
• Aortic stenosis
• Aortic regurgitation (≥ 2+ on a 4-grade scale by Transthoracic Echocardiography).
• 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.
• Left ventricle rupture.
• Cardiac tamponade.
• Subject is scheduled for a staged PCI within 90 days of the index procedure
• 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.
• Chronic renal dysfunction (eGFR \<30 mL/min/1.73 m²) and patients requiring renal replacement therapy with dialysis.
• 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).
• Infection of the proposed procedural access site or suspected systemic active infection, including any fever.

Sponsors & Collaborators

• Magenta Medical Ltd.: lead

Study Sites (2)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

New York-Presbyterian Hospital/Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Study Officials

• Zohar Bronshtine

  Magenta Medical Ltd.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 14, 2023
• Study Start: May 8, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 2, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

US (2)