High-risk Percutaneous Coronary Intervention Clinical Trial
Official title:
Early Feasibility Study (EFS) of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients Undergoing Non-emergent, High-risk Percutaneous Coronary Interventions
The Elevate™ EFS study is designed to evaluate the safety and feasibility of the Magenta Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary interventions.
The Elevate™ EFS is planned as a prospective, single-arm, interventional multi-center study enrolling up to 15 subjects. 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. The Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04477603 -
Impella ECP Early Feasibility Study
|
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 | |
| Active, not recruiting |
NCT06099548 -
Magenta Elevate™ First-in-Human Clinical Study in High-Risk PCI Patients
|
N/A | |
| Not yet recruiting |
NCT06132568 -
VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)
|
N/A |