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

Not Applicable

Recruiting

• Conditions: High-Risk Percutaneous Coronary Intervention
• Interventions: Device: The Elevate™ System

• Registration Number: NCT06099548
• Lead Sponsor: Magenta Medical Ltd.

Brief Summary

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

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 Timeline

• Study Start: 2020-12-17
• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-24
• Study First Posted: 2023-10-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HR-PCI patients	The Elevate™ System	Patients undergoing non-emergent, high-risk percutaneous coronary interventions

Primary Outcome Measures

Name	Time	Method
Device Performance	Through the end of the procedure	Rate of procedural hypotension
Device Safety	Through the end of the procedure	Rate of Major Device-Related Adverse Events

Trial Locations

Locations (2)

Tbilisi Heart and Vascular Clinic; 🇬🇪 Tbilisi, Georgia

Israeli-Georgian Medical Research Clinic "Helsicore"; 🇬🇪 Tbilisi, Georgia