Coronary Artery Disease
Conditions
Keywords
High-risk PCI
Brief 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.
Interventions
Patients are randomized to receive one of two types of percutaneous mechanical circulatory support devices during a high-risk PCI procedure.
Sponsors
Kardion Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACCE | 30 days post-procedure | 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. |
| Device-Related Safety | 30 days post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Device-Related Adverse Events | Index procedure through 30-day follow-up | 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. |
| Individual MACCE components | Index procedure through 30-day follow-up | Individual MACCE components: all-cause death, MI, stroke/TIA, target lesion revascularization, vascular complications, major bleeding, and acute kidney injury. |
| Technical Success | Index procedure | 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. |
| Health Outcomes Measure: all-cause death | Index procedure through 30-day follow-up | all-cause death |
| Death | Index procedure through 30-day follow-up | Cardiovascular death and non-cardiovascular death. |
| Procedural Success | Index Procedure | 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. |
Countries
United States
Contacts
Primary ContactDarin R. Lerew
Outcome results
None listed