PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

Kardion Inc

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Device: Percutaneous Mechanical Circulatory Support

Study type: Interventional

Funder types: Industry

Identifiers

NCT06445608

000001057

Details and patient eligibility

About

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.

Enrollment: 310 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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) 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 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 or calcification 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 as platelet 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 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 < 30 mL/min/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 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, adenosine diphosphate (ADP) receptor blockers, or contrast media, including known heparin-induced thrombocytopenia (HIT)
26. Any non-cardiac condition with life expectancy < 3 years (e.g., cirrhosis, oxygen or oral steroid dependent COPD, cancer, etc.)
27. Subject is presently or recently intubated for the current admission (NOTE: recently intubated patients must be extubated for > 24 hours with full neurologic recovery)
28. Decompensated heart failure requiring IV diuretics, vasopressors, or inotropic support 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 of the investigation
35. Active COVID-19 infection
36. Any anatomical restriction that would preclude an MCS device from being delivered through the femoral artery to the left ventricle
37. 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
38. Current participation in another investigational drug or device trial
39. Anticipated need for continued MCS support after conclusion of the PCI procedure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

KARDION Cory P4 System

Experimental group

Treatment:

Device: Percutaneous Mechanical Circulatory Support

Commercial Control

Active Comparator group

Treatment:

Device: Percutaneous Mechanical Circulatory Support