PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

PICANTE: PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

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 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 ≥32

3. Local heart team (interventional cardiologist, cardiac surgeon) has determined that the subject is an appropriate candidate for a PCI supported with a Mechanical Circulatory Support (MCS) System

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 trial, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)

Exclusion Criteria:

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
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 < 1.8 L/min/m2)
13. Use of inotropic or pressor therapy within 72 hours of the planned index procedure. NOTE: Use of inotropic or pressor therapy for the sole purpose of blood pressure support associated with anesthesia for the procedure is acceptable.
14. Any use of mechanical circulatory support or an extracorporeal membrane oxygenation device within 14 days prior to index procedure
15. Severe aortic valve insufficiency or stenosis or aortic valve replacement
16. Clinically-relevant vascular disease that precludes the placement of a MCS device
17. Cerebrovascular Accident (CVA) within 180 days prior to index procedure
18. Transient Ischemic Attack (TIA) within 90 days prior to index procedure
19. Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000 or spontaneous INR ≥ 1.5 or known fibrinogen ≤ 1.5 g/L)
20. Known hemoglobin diseases, such as sickle cell anemia, hemolytic anemia or thalassemia
21. Subject has evidence of an active infection on the day of the index procedure requiring oral or intravenous antibiotics
22. Active infection of the intended access site
23. Chronic renal dysfunction (eGFR < 30 mL/min/1.73 m²) and/or patients requiring renal replacement therapy with dialysis
24. KnownHistory of liver dysfunction with elevation of liver enzymes and bilirubin 3 times the upper limit of normal (ULN) within 90 days prior to index procedure
25. Known or suspected severe pulmonary disease (e.g., forced expiratory volume (FEV)1 < 1.0 L/s)
26. Allergy, sensitivity or intolerance to anesthesia, heparin, aspirin, adenosine diphosphate (ADP) receptor blockers, or contrast media, including known heparin-induced thrombocytopenia (HIT)
27. Any non-cardiac condition with life expectancy < 1 year
28. Subject is presently or recently intubated for the current admission (NOTE: recently intubated patients must be extubated for > 24 hours with full neurologic recovery). Procedure-related intubation is acceptable.
29. Decompensated heart failure requiring IV diuretics, vasopressors or inotropic support within 72 hours of index procedure
30. Patients with an organ transplant
31. Patients with implanted left ventricular assist device
32. Cardiac tamponade
33. Left ventricular rupture
34. Women who are lactating, pregnant, or plan to become pregnant during the course of the investigation
35. Any anatomical restriction that would preclude a MCS device from being delivered through the femoral artery to the left ventricle
36. Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with trial procedures
37. Current participation in another investigational drug or device trial
38. Anticipated need for continued MCS support after conclusion of the PCI procedure