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

NCT06099548 | Active Not Recruiting

• 1 other identifier: DRD00385
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

High-Risk Percutaneous Coronary Intervention

Keywords

HR-PCI; High-risk percutaneous coronary intervention; Mechanical Circulatory Support; Left ventricular unloading; HRPCI; Temporary MCS

Outcome Measures

Primary Outcomes (2)

• 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

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 (HR-PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.

HR-PCI patients

Eligibility Criteria

• Age: 40 Years - 83 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 ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Magenta Medical Ltd.: lead

Study Sites (2)

Israeli-Georgian Medical Research Clinic "Helsicore"

Tbilisi, Georgia

Location

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Location

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: October 18, 2023
• First Posted: October 25, 2023
• Study Start: December 17, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

GE (2)