Status:
ACTIVE_NOT_RECRUITING
Magenta Elevate™ First-in-Human Clinical Study in High-Risk PCI Patients
Lead Sponsor:
Magenta Medical Ltd.
Conditions:
High-Risk Percutaneous Coronary Intervention
Eligibility:
All Genders
40-83 years
Phase:
NA
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 under...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06099548
Start Date
December 17 2020
End Date
June 1 2026
Last Update
May 30 2025
Active Locations (2)
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1
Israeli-Georgian Medical Research Clinic "Helsicore"
Tbilisi, Georgia
2
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia