BridgeMD
New treatment option for Coronary Artery Disease
Official title PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm
ClinicalTrials.gov ID: NCT06445608
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join 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
You likely can't join 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...
- 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...
- Cardiac arrest within 7 days prior to index procedure requiring CPR or defibrillation
- people with sustained ventricular tachycardia or repetitive/ prolonged non-sustained ventricular tachycardia or complex ventricular ectopy
- Current left ventricular thrombus
See the full eligibility criteria
Who can 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
- 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 (treatment 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)
What rules you out
- 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)...
- 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
- people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Scottsdale, Arizona, United States
- Little Rock, Arkansas, United States
- Thornton, Colorado, United States
- Hartford, Connecticut, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Browns Mills, New Jersey, United States
- New York, New York, United States
- Roslyn, New York, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- York, Pennsylvania, United States
- Nashville, Tennessee, United States
- Seattle, Washington, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Scottsdale, Arizona, United States; Little Rock, Arkansas, United States; Thornton, Colorado, United States; Hartford, Connecticut, United States; Jacksonville, Florida, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.