Magenta Elevate™ First-in-Human Clinical Study in High-Risk PCI Patients

Study Overview
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Brief Summary
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The Elevate™ First-In-Human (FIH) study is designed to evaluate the initial safety and device functionality of the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary interventions.

Detailed Description
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The Elevate™ System FIH study is planned as a prospective, single-arm, interventional study of up to 20 patients. The Magenta Elevate™ 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. 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.

Official Title
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First-in-Human (FIH) Clinical Investigation Protocol of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients Undergoing Non-emergent, High-risk Percutaneous Coronary Interventions (ELEVATE I)

Conditions
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High-Risk Percutaneous Coronary Intervention

Intervention / Treatment
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* Device: The Elevate™ System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 ≤ 45% 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) Femoral artery diameter compatible with the use of Elevate™ Subject signed informed consent Exclusion Criteria: Subject age < 40 or ≥ 83 years Cardiogenic shock Left ventricular mural thrombus Presence of a mechanical aortic valve or a heart-constrictive device Aortic stenosis Moderate or severe aortic regurgitation (≥ 2+ by Transthoracic Echocardiography) Severe peripheral vascular disease Aortic pathology, such as aortic aneurysms, extreme tortuosity or calcifications that could pose an undue additional risk to the placement of a pLVAD device Chronic renal dysfunction (serum creatinine ≥ 3.5 mg/dL) Uncorrectable abnormal coagulation parameters (defined as platelet count ≤ 75,000 or INR ≥ 2.0 or fibrinogen ≤ 1.5 g/L) Active systemic infection Stroke or transient ischemic attack within 3 months of enrollment Female subjects who are pregnant or breast-feeding

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 83 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HR-PCI patients<br>Patients undergoing non-emergent, high-risk percutaneous coronary interventions | Device: The Elevate™ System<br>* The Magenta Elevate™ 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Performance | Rate of procedural hypotension | Through the end of the procedure | 
| Device Safety | Rate of Major Device-Related Adverse Events | Through the end of the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HR-PCI, High-risk percutaneous coronary intervention, Mechanical Circulatory Support, Left ventricular unloading, HRPCI, Temporary MCS