Magenta Elevate™ First-in-Human Clinical Study in High-Risk PCI Patients (ELEVATE I)

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: High-Risk Percutaneous Coronary Intervention
• Intervention / Treatment: Device: The Elevate™ System

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia
    • Israeli-Georgian Medical Research Clinic "Helsicore"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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 ≤ 45% 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. Femoral artery diameter compatible with the use of Elevate™
4. Subject signed informed consent

Exclusion Criteria:

1. Subject age < 40 or ≥ 83 years
2. Cardiogenic shock
3. Left ventricular mural thrombus
4. Presence of a mechanical aortic valve or a heart-constrictive device
5. Aortic stenosis
6. Moderate or severe aortic regurgitation (≥ 2+ by Transthoracic Echocardiography)
7. Severe peripheral vascular disease
8. Aortic pathology, such as aortic aneurysms, extreme tortuosity or calcifications that could pose an undue additional risk to the placement of a pLVAD device
9. Chronic renal dysfunction (serum creatinine ≥ 3.5 mg/dL)
10. Uncorrectable abnormal coagulation parameters (defined as platelet count ≤ 75,000 or INR ≥ 2.0 or fibrinogen ≤ 1.5 g/L)
11. Active systemic infection
12. Stroke or transient ischemic attack within 3 months of enrollment
13. Female subjects who are pregnant or breast-feeding

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 (HR-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
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

Collaborators and Investigators

• Sponsor: Magenta Medical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Actual): September 7, 2022
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Mechanical Circulatory Support; HRPCI; High-risk percutaneous coronary intervention; Left ventricular unloading; HR-PCI; Temporary MCS
• Other Study ID Numbers: DRD00385

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No