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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06099548
Other study ID # DRD00385
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04477603 - Impella ECP Early Feasibility Study N/A
Recruiting NCT06132568 - VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS) N/A
Recruiting NCT05727059 - Magenta Elevate™ EFS in High-Risk PCI Patients N/A
Recruiting NCT04321148 - Protect Kidney Trial N/A
Enrolling by invitation NCT05334784 - Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol N/A