PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

Recruiting now · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT06445608

Run by

Kardion Inc

People needed

310

Starts

2024-09-03

Expected to finish

2025-12-01

Last updated by the study team

2025-06-13

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject age ≥ 18 and ≤ 90 years at the time of screening
• 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
• 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
• Confirmed access site vasculature greater than 5.5 mm as measured by CT or femoral duplex ultrasound
• The subject is willing and able to comply with the protocol-specified treatment and follow-up evaluations
• 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)

You may not qualify if…

• Any prior coronary revascularization or revascularization attempt within 30 days prior to index procedure
• 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
• 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
• Cardiac arrest within 7 days prior to index procedure requiring CPR or defibrillation
• Subjects with sustained ventricular tachycardia or repetitive/ prolonged non-sustained ventricular tachycardia or complex ventricular ectopy
• Current left ventricular thrombus
• Significant right heart failure (right ventricular fractional area change <35% on echocardiography)
• Known severe pulmonary hypertension (right ventricular systolic pressure (RVSP) on echo or pulmonary artery systolic pressure (PASP) on right heart catheterization > 70mmHg
• Combined cardiorespiratory failure
• Presence of an atrial or ventricular septal defect (including post-infarct VSD)
• Hypertrophic obstructive cardiomyopathy (HOCM), restrictive cardiomyopathy, or constrictive pericarditis
• Cardiogenic shock (Cardiac index < 1.8 L/min/m2)
• 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.
• Any use of mechanical circulatory support or an extracorporeal membrane oxygenation device within 14 days prior to index procedure
• Severe aortic valve insufficiency or stenosis or aortic valve replacement
• Clinically-relevant vascular disease that precludes the placement of a MCS device
• Cerebrovascular Accident (CVA) within 180 days prior to index procedure
• Transient Ischemic Attack (TIA) within 90 days prior to index procedure
• 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)
• Known hemoglobin diseases, such as sickle cell anemia, hemolytic anemia or thalassemia
• Subject has evidence of an active infection on the day of the index procedure requiring oral or intravenous antibiotics
• Active infection of the intended access site
• Chronic renal dysfunction (eGFR < 30 mL/min/1.73 m²) and/or patients requiring renal replacement therapy with dialysis
• 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
• Known or suspected severe pulmonary disease (e.g., forced expiratory volume (FEV)1 < 1.0 L/s)

Where it is running

• University of Washington — Seattle, Washington, United States (enrolling)
• HonorHealth Research and Innovation Institute — Scottsdale, Arizona, United States (enrolling)
• Arkansas Cardiology, P.A. — Little Rock, Arkansas, United States (enrolling)
• North Suburban Medical Center — Thornton, Colorado, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• Ascension St. Vincent's — Jacksonville, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Ascension St. Vincent — Indianapolis, Indiana, United States (enrolling)
• Dignity Health - Chandler Regional Medical Center — Chandler, Arizona, United States (enrolling)
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (enrolling)
• Deborah Heart and Lung Center — Browns Mills, New Jersey, United States (enrolling)
• Mount Sinai — New York, New York, United States (enrolling)
• St. Francis Hospital — Roslyn, New York, United States (enrolling)
• The Lindner Research Center at The Christ Hospital — Cincinnati, Ohio, United States (enrolling)
• Ohio Health Research Institute — Columbus, Ohio, United States (enrolling)
• Heart and Vascular Research at WellSpan Health — York, Pennsylvania, United States (enrolling)
• Ascension Saint Thomas — Nashville, Tennessee, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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