PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06445608
• Other study ID #: 000001057
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Kardion Inc
• Contact: Darin R. Lerew
• Phone: 651-707-3795
• Email: darin.lerew[@]kardion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 310
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Percutaneous Mechanical Circulatory Support
Patients are randomized to receive one of two types of percutaneous mechanical circulatory support devices during a high-risk PCI procedure.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kardion Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACCE	The primary effectiveness endpoint of the clinical investigation is a composite endpoint of major adverse cardiac and cerebrovascular events (MACCE) comprised of all-cause death, myocardial infarction, stroke/TIA, target lesion revascularization, vascular complications, major bleeding, and acute kidney injury.	30 days post-procedure
Primary	Device-Related Safety	The primary safety endpoint of the clinical investigation is a composite endpoint of device-related safety events (as adjudicated by the CEC) requiring intervention, including cardiac or vascular complication, limb ischemia, increase in aortic insufficiency, or CPR or ventricular arrhythmia requiring cardioversion.	30 days post-procedure
Secondary	Technical Success	Technical Success defined as the ability of the MCS System to be delivered, operated without device malfunction through the end of procedure, and successful retrieval.	Index procedure
Secondary	Procedural Success	Procedural Success defined as Technical Success and the ability of the MCS System to provide hemodynamic support preventing severe hypotension and without the need for escalation of mechanical circulatory support (i.e., replacement of the MCS System with a higher output mechanical circulatory support device). Severe hypotension defined as requiring continuous infusion of inotropic/pressor medications to restore hemodynamics to mean arterial pressure greater than 60 mmHg.	Index Procedure
Secondary	Serious Device-Related Adverse Events	Safety Outcome defined as Serious Device-Related Adverse Events (defined as any Serious Adverse Event adjudicated as related to the device by the Clinical Events Committee (CEC)) through 30 days following the index procedure.	Index procedure through 30-day follow-up
Secondary	Individual MACCE components	Individual MACCE components: all-cause death, MI, stroke/TIA, target lesion revascularization, vascular complications, major bleeding, and acute kidney injury.	Index procedure through 30-day follow-up
Secondary	Death	Cardiovascular death and non-cardiovascular death.	Index procedure through 30-day follow-up