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

High-Risk Percutaneous Coronary Intervention Clinical Trial

— ELEVATE I  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06099548
• Other study ID #: DRD00385
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 17, 2020
• Est. completion date: March 2024

Study information

• Verified date: September 2023
• Source: Magenta Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: March 2024
• Est. primary completion date: September 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 83 Years

Eligibility

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

Related Conditions & MeSH terms

• High-Risk Percutaneous Coronary Intervention

Intervention

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.

Locations

Country	Name	City	State
Georgia	Israeli-Georgian Medical Research Clinic "Helsicore"	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Magenta Medical Ltd.

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Performance	Rate of procedural hypotension	Through the end of the procedure
Primary	Device Safety	Rate of Major Device-Related Adverse Events	Through the end of the procedure