PICANTE: PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm
Kardion Inc
Summary
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.
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DevicePercutaneous Mechanical Circulatory Support
Patients are randomized to receive one of two types of percutaneous mechanical circulatory support devices during a high-risk PCI procedure.
Locations (18)
- Dignity Health - Chandler Regional Medical CenterChandler, Arizona
- HonorHealth Research and Innovation InstituteScottsdale, Arizona
- Arkansas Cardiology, P.A.Little Rock, Arkansas
- North Suburban Medical CenterThornton, Colorado
- Hartford HospitalHartford, Connecticut
- Ascension St. Vincent'sJacksonville, Florida