percutaneous coronary intervention percutaneous coronary intervention
Conditions
Interventions
Experimental Device
Mechanical circulatory support
Sponsors
Kardion, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria: 1. Subject age greater than or equal to 18 and less than or equal to 90 years at the time of screening 2. The subject has an LV ejection fraction of less than or equal to 50 percent (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 Intended calcium modification (by atherectomy, lithotripsy or laser): In multiple vessels OR In the left main OR In a final patent conduit OR Where the anatomic SYNTAX score is greater than or equal to 32 3. The subject is an appropriate candidate for a PCI supported with a Mechanical Circulatory Support (MCS) System (e.g., non-emergent PCI, has been deemed to be suboptimal for cardiac surgery, requires hemodynamic support during the PCI procedure, does not have other diseases or therapies that restrict the use of an MCS System, and not expected to require cardiac support with an MCS System post-PCI procedure). 4. Confirmed access site vasculature greater than 5.5 mm as measured by CT or femoral duplex ultrasound 5. The subject is willing and able to comply with the protocol-specified treatment and follow-up evaluations. 6. The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
Exclusion criteria
Exclusion criteria: Subjects must not meet any of the following criteria: 1. Any prior coronary revascularization or revascularization attempt within 30 days prior to procedure 2. STEMI within 7 days prior to procedure defined as new ST elevation at the J point in at least 2 contiguous leads of greater than or equal to 2 mm (0.2 mV) in men or greater than or equal to 1.5 mm (0.15 mV) in women in leads V2 V3 and or of greater than or equal to 1 mm (0.1 mV) in other contiguous chest leads or the limb leads 3. Non-STEMI within 7 days prior to procedure with an elevated cardiac biomarker (CK MB or Troponin greater than 1x ULN) without CK MB or Troponin value down trending 4. Cardiac arrest within 7 days prior to procedure requiring CPR or defibrillation 5. Subjects with sustained ventricular tachycardia or repetitive or prolonged non-sustained ventricular tachycardia or complex ventricular ectopy 6. Current left ventricular thrombus 7. Significant right heart failure (right ventricular fractional area change less than 35 percent on echocardiography) 8. Known severe pulmonary hypertension (right ventricular systolic pressure (RVSP) on echo or pulmonary artery systolic pressure (PASP) on right heart catheterization greater than 70mmHg 9. Combined cardiorespiratory failure 10. Presence of an atrial or ventricular septal defect (including post-infarct VSD) 11. Hypertrophic obstructive cardiomyopathy (HOCM), restrictive cardiomyopathy, or constrictive pericarditis 12. Cardiogenic shock (Cardiac index less than 1.8 l per min per m2) or pre-procedure use of inotropic or pressor therapy within 72 hours of the planned index procedure 13. Any use of mechanical circulatory support or an extracorporeal membrane oxygenation device within 14 days 14. Severe aortic valve insufficiency or stenosis or aortic valve replacement 15. Aortic vascular disease (i.e., aortic aneurysm, dissection, extreme tortuosity or calcification that creates additional risk to the placement of a MCS device) 16. Cerebrovascular Accident (CVA) within 180 days prior to procedure 17. Transient Ischemic Attack (TIA) within 90 days prior to procedure 18. Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count less than or equal to 100,000 or spontaneous INR greater than or equal to 1.5 or known fibrinogen less than or equal to 1.5 g per l) 19. Known hemoglobin diseases, such as sickle cell anemia, hemolytic anemia or thalassemia 20. Subject has evidence of an active infection on the day of the index procedure requiring oral or intravenous antibiotics 21. Active infection of the intended access site 22. Chronic renal dysfunction (eGFR less than 30 mL per min per 1.73 m2) and/or patients requiring renal replacement therapy with dialysis 23. History of liver dysfunction with elevation of liver enzymes and bilirubin 3 times the upper limit of normal (ULN) within 90 days prior to procedure 24. Known or suspected severe pulmonary disease (e.g., forced expiratory volume (FEV)1 less than 1.0 l per s) 25. Allergy, sensitivity or intolerance to anesthesia, heparin, aspirin, adenosine diphosphate (ADP) receptor blockers, or contrast media, including known heparin-induced thrombocytopenia (HIT) 26. Any non-cardiac condition with life expectancy less than 3 years (e.g., cirrhosis, oxygen or oral steroid dependent COPD, cancer, etc.) 27. Subject is presently or recently intubated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device related serious adverse events Through discharge or up to 3 days, whichever occurs first Observational | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical Success Index procedure defined as the ability of the CORY P4K Device to be delivered, operated without device malfunction through the end of procedure, and successful retrieval,Procedure success Index procedure defined as Technical Success and the ability of the CORY P4K Device to provide hemodynamic support preventing severe hypotension and without the need for escalation of mechanical circulatory support ,Procedure success of the CORY P4 kSheath Index procedure defined as successful insertion and retrieval of the CORY P4K Device through the CORY P4 KSheath ,Device related access site complications Through discharge or up to 3 days, whichever occurs first Observational,Device related major bleeding events (BARC greater than or equal to 3) Through discharge or up to 3 days, whichever occurs first Observational,All device and procedure related adverse events Through discharge or up to 3 days, whichever occurs first Observational | — |
Countries
Paraguay
Contacts
Public ContactAdrian Ebner
Italian Hospital Asuncion
Outcome results
None listed