High-Risk Percutaneous Coronary Intervention
Conditions
Keywords
HR-PCI, High-risk percutaneous coronary intervention, Mechanical Circulatory Support, Left ventricular unloading, HRPCI, Temporary MCS
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.
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.
Interventions
DEVICEThe 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.
Sponsors
Magenta Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 83 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Georgia
Outcome results
None listed