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

NCT ID: NCT06099548

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-17
• Study Completion Date: 2026-06-01

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.

Conditions

High-Risk Percutaneous Coronary Intervention

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HR-PCI patients

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

Group Type: EXPERIMENTAL

The Elevate™ System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 83 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Magenta Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Israeli-Georgian Medical Research Clinic "Helsicore"

Tbilisi, , Georgia

Tbilisi Heart and Vascular Clinic

Tbilisi, , Georgia

Countries

Georgia

Other Identifiers

DRD00385

Identifier Type: -

Identifier Source: org_study_id