Kardion Inc
This purpose of this trial is to demonstrate 30 day safety and effectiveness outcomes of the KARDION CORY P4 System in subjects who require hemodynamic support during a high-risk PCI procedure.
Inclusion Criteria: 1. Subject age ≥ 18 and ≤ 90 years at the time of screening 2. The subject has an LV ejection fraction of \< 50% (within 90 days of index procedure) AND is at high-risk due to any of the following: * Unprotected left main coronary artery stenosis disease * Last remaining epicardial native coronary artery * Significant three vessel coronary artery disease * Significant two vessel coronary artery disease of complex lesions * Significant single vessel coronary artery disease of complex lesions and non-treated CTO * Target vessel is a CTO with planned retrog…
Patients are randomized to receive one of two types of percutaneous mechanical circulatory support devices during a high-risk PCI procedure.