PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

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 andnon-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 thatthe subject is an appropriate candidate for a PCI supported with a MechanicalCirculatory Support (MCS) System

4. Confirmed access site vasculature greater than 5.5 mm as measured by CT or femoralduplex ultrasound

5. The subject is willing and able to comply with the protocol-specified treatment andfollow-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 InstitutionalReview Board (IRB) or Ethics Committee (EC)

Exclusion Criteria:

1. Any prior coronary revascularization or revascularization attempt within 30 daysprior to index procedure

2. STEMI within 7 days prior to index procedure - defined as new ST elevation at the Jpoint 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 orthe 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 ordefibrillation

5. Subjects with sustained ventricular tachycardia or repetitive/ prolongednon-sustained ventricular tachycardia or complex ventricular ectopy

6. Current left ventricular thrombus

7. Significant right heart failure (right ventricular fractional area change <35% onechocardiography)

8. Known severe pulmonary hypertension (right ventricular systolic pressure (RVSP) onecho 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, orconstrictive pericarditis

12. Cardiogenic shock (Cardiac index < 1.8 l/min/m2) or pre-procedure use of inotropicor pressor therapy within 72 hours of the planned index procedure

13. Any use of mechanical circulatory support or an extracorporeal membrane oxygenationdevice within 14 days prior to index procedure

14. Severe aortic valve insufficiency or stenosis or aortic valve replacement

15. Aortic vascular disease (i.e., aortic aneurysm, dissection, extreme tortuosity orcalcification that creates additional risk to the placement of a MCS device)

16. Cerebrovascular Accident (CVA) within 180 days prior to index procedure

17. Transient Ischemic Attack (TIA) within 90 days prior to index procedure

18. Known or suspected coagulopathy or abnormal coagulation parameters (defined asplatelet count ≤ 100,000 or spontaneous INR ≥ 1.5 or known fibrinogen ≤ 1.5 g/l)

19. Known hemoglobin diseases, such as sickle cell anemia, hemolytic anemia orthalassemia

20. Subject has evidence of an active infection on the day of the index procedurerequiring oral or intravenous antibiotics

21. Active infection of the intended access site

22. Chronic renal dysfunction (eGFR < 30 mL/min/1.73 m²) and/or patients requiring renalreplacement therapy with dialysis

23. History of liver dysfunction with elevation of liver enzymes and bilirubin 3 timesthe upper limit of normal (ULN) within 90 days prior to index procedure

24. Known or suspected severe pulmonary disease (e.g., forced expiratory volume (FEV)1 < 1.0 l/s)

25. Allergy, sensitivity or intolerance to anesthesia, heparin, aspirin, adenosinediphosphate (ADP) receptor blockers, or contrast media, including knownheparin-induced thrombocytopenia (HIT)

26. Any non-cardiac condition with life expectancy < 3 years (e.g., cirrhosis, oxygen ororal steroid dependent COPD, cancer, etc.)

27. Subject is presently or recently intubated for the current admission (NOTE: recentlyintubated patients must be extubated for > 24 hours with full neurologic recovery)

28. Decompensated heart failure requiring IV diuretics, vasopressors, or inotropicsupport within 2 days of index procedure

29. Morbid obesity (BMI ≥ 40 kg/m²)

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 ofthe investigation

35. Active COVID-19 infection

36. Any anatomical restriction that would preclude an MCS device from being deliveredthrough the femoral artery to the left ventricle

37. Subject has other medical, social or psychological problems that, in the opinion ofthe Investigator, compromises the subject's ability to give written informed consentand/or to comply with trial procedures

38. Current participation in another investigational drug or device trial

39. Anticipated need for continued MCS support after conclusion of the PCI procedure