Coronary Artery DiseaseNCT06445608
PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm
A study testing Percutaneous Mechanical Circulatory Support in people with Coronary Artery Disease, run by Kardion Inc at 18 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous Mechanical Circulatory Support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 18 sitesUnited States
- Study dates
- 3 Sep 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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)
- Allergy, sensitivity or intolerance to anesthesia, heparin, aspirin, adenosine diphosphate (ADP) receptor blockers, or contrast media, including known heparin-induced thrombocytopenia (HIT)
- Any non-cardiac condition with life expectancy < 1 year
- 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.
- Decompensated heart failure requiring IV diuretics, vasopressors or inotropic support within 72 hours of index procedure
- Patients with an organ transplant
- Patients with implanted left ventricular assist device
- Cardiac tamponade
- Left ventricular rupture
- Women who are lactating, pregnant, or plan to become pregnant during the course of the investigation
- Any anatomical restriction that would preclude a MCS device from being delivered through the femoral artery to the left ventricle
- 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
- Current participation in another investigational drug or device trial
- Anticipated need for continued MCS support after conclusion of the PCI procedure
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 17 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
William Nicholson, MD, 404-712-7665
- Withdrawn
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Muhmammad Raza, MD, 604-893-1200 ext. 5032, razam@deborah.org
- Recruiting
Dignity Health - Chandler Regional Medical Center
Chandler, Arizona, 85224
Ashish Pershad, MD, 480-728-9973, ashish.pershad@dignityhealth.org
- Recruiting
The Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, 45219
Jarrod Frizzell, MD, 513-585-1777, Jarrod.Frizzell@thechristhospital.com
- Recruiting
Ohio Health Research Institute
Columbus, Ohio, 43214
Arash Arshi, MD, 614-262-6772, arash.arshi@ohiohealth.com
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06112
Craig Thompson, MD, 802-369-6250, craig.thompson@hhchealth.org
- Recruiting
Ascension St. Vincent
Indianapolis, Indiana, 46290
Michael Kourany, MD, 317-338-8042, mjkouran@ascension.org
- Recruiting
Ascension St. Vincent's
Jacksonville, Florida, 32204
Samer Garas, MD, 904-308-5763, samergaras@yahoo.com
- Recruiting
Arkansas Cardiology, P.A.
Little Rock, Arkansas, 72205
Ernesto Ruiz-Rodriguez, MD, 501-227-7596 ext. 1263, eruizrodz@gmail.com
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Emmanouil Brilakis, MD, 612-863-3895, emmanouil.brilakis@allina.com
- Recruiting
Ascension Saint Thomas
Nashville, Tennessee, 37205
Jimmy Kerrigan, MD, 615-269-4545, jimmy.kerrigan@ascension.org
- Recruiting
Mount Sinai
New York, New York, 10029
Samin Sharma, 212-241-9687, samin.sharma@mountsinai.org
- Recruiting
St. Francis Hospital
Roslyn, New York, 11576
Allen Jeremias, MD, 516-562-6790, allen.jeremias@chsli.org
- Recruiting
HonorHealth Research and Innovation Institute
Scottsdale, Arizona, 85258
Taral Patel, MD, 480-323-1046, tpatel@honorhealth.com
- Recruiting
University of Washington
Seattle, Washington, 98195
Kathleen Kearney, MD, 206-221-9154, kakearney@cardiology.washington.edu
- Recruiting
North Suburban Medical Center
Thornton, Colorado, 80229
Ehrin Armstrong, MD, 415-312-2480, earmstrong@clinre.com
- Recruiting
Heart and Vascular Research at WellSpan Health
York, Pennsylvania, 17403
Stewart Benton, MD, 717-851-2441, sbenton@wellspan.org
About this study
Official title: PICANTE: PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous Mechanical Circulatory Support
- Keywords
- High-risk PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Mechanical Circulatory SupportDevice
Patients are randomized to receive one of two types of percutaneous mechanical circulatory support devices during a high-risk PCI procedure.
| Study group | Role | What they receive |
|---|---|---|
| KARDION Cory P4 System | Experimental | Not described Receives: Device: Percutaneous Mechanical Circulatory Support |
| Commercial Control | Active comparator | Not described Receives: Device: Percutaneous Mechanical Circulatory Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post-procedure
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.
Measured: 30 days post-procedure
Secondary outcomes (6)
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.
Measured: Index procedure
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.
Measured: Index Procedure
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.
Measured: Index procedure through 30-day follow-up
Individual MACCE components
Individual MACCE components: all-cause death, MI, stroke/TIA, target lesion revascularization, vascular complications, major bleeding, and acute kidney injury.
Measured: Index procedure through 30-day follow-up
Death
Cardiovascular death and non-cardiovascular death.
Measured: Index procedure through 30-day follow-up
Health Outcomes Measure: all-cause death
all-cause death
Measured: Index procedure through 30-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start3 Sep 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kardion Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samin Sharma, MD, Study chair, Icahn School of Medicine at Mount SinaiWilliam Nicholson, MD, Study chair, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445608
- Sponsor's protocol ID
- 000001057
- Status last verified
- Jun 2025
- First submitted
- 31 May 2024
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PICANTE: PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm
- ClinicalTrials.gov ID
- NCT06445608
- Acronym / sponsor ID
- 000001057
- Conditions
- Coronary Artery Disease
- Keywords
- High-risk PCI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Kardion IncIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KARDION Cory P4 System | Experimental | Device: Percutaneous Mechanical Circulatory Support |
| Commercial Control | Active comparator | Device: Percutaneous Mechanical Circulatory Support |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- 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
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Mechanical Circulatory SupportPatients are randomized to receive one of two types of percutaneous mechanical circulatory support devices during a high-risk PCI procedure. | Device | Commercial Control, KARDION Cory P4 System |
Primary outcome
MACCE
Time frame: 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
Time frame: 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.
6 secondary outcomes
Technical Success
Time frame: Index procedure
Procedural Success
Time frame: Index Procedure
Serious Device-Related Adverse Events
Time frame: Index procedure through 30-day follow-up
Individual MACCE components
Time frame: Index procedure through 30-day follow-up
Death
Time frame: Index procedure through 30-day follow-up
Health Outcomes Measure: all-cause death
Time frame: Index procedure through 30-day follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samin Sharma, MD study chair
Icahn School of Medicine at Mount Sinai
William Nicholson, MD study chair
Emory University
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Mechanical Circulatory Support in people with Coronary Artery Disease, run by Kardion Inc at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Darin R. Lerew (612-276-2716, darin.lerew@kardion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE (time frame: 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.