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

Sponsor

Magenta Medical Ltd. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT06099548

Collaborator

(none)

Enrollment

Location

Arm

38.4

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
High-Risk Percutaneous Coronary Intervention	Device: The Elevate™ System	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Dec 17, 2020

Actual Primary Completion Date :

Sep 7, 2022

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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.

Arm

Intervention/Treatment

Experimental: HR-PCI patients

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

Device: The Elevate™ System

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 83 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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