Actively Recruiting
PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm
Led by Kardion Inc · Updated on 2025-06-13
310
Participants Needed
18
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 90 years at screening
- Left ventricular ejection fraction less than 50% within 90 days before the procedure
- High-risk coronary artery disease due to conditions such as unprotected left main artery stenosis, last remaining native coronary artery, significant multi-vessel disease, complex lesions, chronic total occlusion with planned retrograde approach, or intended calcium modification
- Heart team approval confirming suitability for PCI with mechanical circulatory support
- Confirmed access site vasculature larger than 5.5 mm by CT or ultrasound
- Ability and willingness to comply with treatment and follow-up
- Provided informed consent approved by Institutional Review Board or Ethics Committee
You will not qualify if you...
- Prior coronary revascularization or attempt within 30 days before the procedure
- STEMI or non-STEMI heart attack within 7 days prior to procedure
- Cardiac arrest requiring CPR or defibrillation within 7 days
- Sustained or complex ventricular arrhythmias
- Left ventricular thrombus
- Significant right heart failure or severe pulmonary hypertension
- Combined heart and respiratory failure
- Atrial or ventricular septal defects
- Certain cardiomyopathies or constrictive pericarditis
- Cardiogenic shock with low cardiac index
- Use of inotropic or pressor therapy within 72 hours before procedure (unless anesthesia-related)
- Mechanical circulatory support or ECMO use within 14 days prior
- Severe aortic valve disease or replacement
- Vascular disease preventing device placement
- Recent stroke or transient ischemic attack
- Coagulopathy or abnormal blood clotting
- Hemoglobin diseases like sickle cell anemia
- Active infection requiring antibiotics or at access site
- Severe kidney or liver dysfunction
- Severe pulmonary disease
- Allergies to anesthesia, heparin, aspirin, ADP receptor blockers, or contrast media
- Life expectancy less than 1 year due to non-cardiac conditions
- Recent or current intubation without full recovery
- Decompensated heart failure needing IV treatment within 72 hours
- Organ transplant or implanted ventricular assist device
- Cardiac tamponade or left ventricular rupture
- Pregnancy, lactation, or plans to become pregnant during study
- Anatomical restrictions preventing device delivery
- Other medical, social, or psychological issues affecting consent or compliance
- Current participation in other investigational drug or device trials
- Expected need for mechanical circulatory support after PCI procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Dignity Health - Chandler Regional Medical Center
Chandler, Arizona, United States, 85224
Actively Recruiting
2
HonorHealth Research and Innovation Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
Arkansas Cardiology, P.A.
Little Rock, Arkansas, United States, 72205
Actively Recruiting
4
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Actively Recruiting
5
Hartford Hospital
Hartford, Connecticut, United States, 06112
Actively Recruiting
6
Ascension St. Vincent's
Jacksonville, Florida, United States, 32204
Actively Recruiting
7
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
Ascension St. Vincent
Indianapolis, Indiana, United States, 46290
Actively Recruiting
9
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Withdrawn
10
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
11
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States, 08015
Actively Recruiting
12
Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
13
St. Francis Hospital
Roslyn, New York, United States, 11576
Actively Recruiting
14
The Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
15
Ohio Health Research Institute
Columbus, Ohio, United States, 43214
Actively Recruiting
16
Heart and Vascular Research at WellSpan Health
York, Pennsylvania, United States, 17403
Actively Recruiting
17
Ascension Saint Thomas
Nashville, Tennessee, United States, 37205
Actively Recruiting
18
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
D
Darin R. Lerew
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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