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KARDION CORY P4 System for High-Risk PCI

This study is testing the KARDION CORY P4 System, a type of mechanical circulatory support device, during a high-risk PCI (Percutaneous Coronary Intervention - a procedure to open blocked heart arteries). The goal is to see how safe and effective this device is for people with coronary artery disease who need support during their procedure. You might be able to join if you are between 18 and 90 years old, have a heart pumping ability (LV ejection fraction) of less than 50%, and have complex coronary artery disease. The study will measure major heart events and device-related safety 30 days after the procedure. The current recruitment status is unclear.

Study design
This study plans to enroll 310 participants. You will be randomly assigned to receive one of two types of mechanical circulatory support devices.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and effectiveness outcomes will be measured 30 days after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06445608

PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

Recruiting
NAAges 18–90InterventionalTreatment
Kardion Inc
~310 participants
Updated 2025-06-13 on ClinicalTrials.gov
What's tested:Percutaneous Mechanical Circulatory Support

At a glance

Recruiting sites
17 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MACCE
Measured over 30 days post-procedure
+1 more outcome measured

Conditions

Coronary Artery Disease

Explore related trials

Coronary Artery DiseaseHigh-risk PCI

Where it's being run

18 sites across 15 states
Arizona2
New York2
Ohio2
Arkansas1
Colorado1
Connecticut1
Florida1
Georgia1

Study leadership

  • Samin Sharma, MD · STUDY_CHAIR · Icahn School of Medicine at Mount Sinai
  • William Nicholson, MD · STUDY_CHAIR · Emory University

Who to contact

Darin R. Lerew
[email protected]
612-276-2716
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

What this trial measures

  • MACCE30 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 Safety30 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.