Magenta Elevateâ„¢ First-in-Human Clinical Study in High-Risk PCI Patients (NCT06099548) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Magenta Elevateâ„¢ First-in-Human Clinical Study in High-Risk PCI Patients
Georgia20 participantsStarted 2020-12-17
Plain-language summary
The Elevateâ„¢ First-In-Human (FIH) study is designed to evaluate the initial safety and device functionality of the Elevateâ„¢ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary interventions.
Who can participate
Age range40 Years – 83 Years
SexALL
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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)
✕. Aortic pathology, such as aortic aneurysms, extreme tortuosity or calcifications that could pose an undue additional risk to the placement of a pLVAD device