RecruitingCoronary Artery Disease

PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

Eligible age

18–90 yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

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About this study

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.

Sponsor: Kardion Inc

You may qualify if…

✓ 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 retrograde approach

You may not qualify if…

✕ 1. Any prior coronary revascularization or revascularization attempt within 30 days prior to index procedure
✕ 2. STEMI within 7 days prior to index procedure - defined as new ST elevation at the J point in at least 2 contiguous leads of ≥ 2 mm (0.2 mV) in men or ≥ 1.5 mm (0.15 mV) in women in leads V2-V3 and/or of ≥ 1 mm (0.1 mV) in other contiguous chest leads or the limb leads
✕ 3. Non-STEMI within 7 days prior to index procedure with an elevated cardiac biomarker (CK-MB or Troponin \>1x ULN) without CK-MB or Troponin value down trending
✕ 4. Cardiac arrest within 7 days prior to index procedure requiring CPR or defibrillation
✕ 5. Subjects with sustained ventricular tachycardia or repetitive/ prolonged non-sustained ventricular tachycardia or complex ventricular ectopy
✕ 6. Current left ventricular thrombus
✕ 7. Significant right heart failure (right ventricular fractional area change \<35% on echocardiography)
✕ 8. Known severe pulmonary hypertension (right ventricular systolic pressure (RVSP) on echo or pulmonary artery systolic pressure (PASP) on right heart catheterization \> 70mmHg