High-risk Percutaneous Coronary Intervention Clinical Trial
Official title:
VITALYST EFS: VITALYST Temporary Percutaneous Transvalvular Circulatory Support System Early Feasibility Study
The VITALYST Early Feasibility study (EFS) is designed to evaluate the feasibility and safety of the VITALYST System in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).
The VITALYST EFS is a prospective, open-label, single-arm, multicenter feasibility study of the VITALYST System. The VITALYST System will be used to provide temporary circulatory support in patients undergoing non-emergent high risk percutaneous interventions (HR-PCI). ;
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