Ensayos clínicos

Inclusion Criteria 

• At least 18 years of age
• Undergoing elective or urgent high risk percutaneous coronary intervention procedure and is hemodynamically stable
• Is indicated for a revascularization of at least one new or restenotic lesion in a native coronary vessel or bypass graft 
• A heart team that includes a Cardiac Surgeon who has seen the patient, has determined with concurrence of the Cardiac Surgeon member, that high risk PCI is the appropriate therapeutic option 
• The presence of complex coronary artery disease (CAD) makes hemodynamic instability resulting from repeat episodes of reversible myocardial ischemia during PCI likely. Complex CAD is defined as
  • An ejection fraction of ≤35% and at least one of the following
    • Intervention of the last patent coronary conduit
    • Intervention of an unprotected left main artery 
    • An ejection fraction of ≤35% and intervention on patient presenting with triple vessel disease defined as at least one significant stenosis (at least 50% diameter stenosis on visual assessment) in all three major epicardial territories 
• Written, signed, and dated informed consent

Exclusion Criteria

• Emergency PCI 
• Myocardial infarction at baseline 
• Cardiac arrest within 24 hours of procedure requiring CPR or defibrillation 
• Hemodynamic support with the HeartMate PHP post-PCI is anticipated 
• Cardiogenic shock
  • Systolic blood pressure <90 mmHg for >1 hour with either cool clammy skin 
  • Oliguria 
  • Altered sensorium and cardiac index <2.2 L/min/m2
• Mural thrombus in the left ventricle 
• History of aortic valve replacement 
• Documented presence of aortic stenosis with orifice area of 1.5cm2 or less
• Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher)
• Severe peripheral vascular disease
• Abnormalities of the aorta that would preclude surgery, including aneurysms and significant tortuosity or calcifications
• Is on hemodialysis 
• Liver dysfunction with elevation of liver enzymes and
  • bilirubin levels to ≥ 3x upper limit of normal (ULN) 
  • INR (Internationalized Normalized Ratio) ≥2 
  • lactate dehydrogenase (LDH) > 2.5x ULN
• Uncorrectable abnormal coagulation parameters (platelet count ≤75000/mm3 
• INR ≥2.0 or fibrinogen ≤1.5 g/l)
• Active systemic infection requiring treatment with antibiotics
• Stroke or transient ischemic attack (TIA) within 6 month of procedure
• Any allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated 
• Pregnant 
• Participation in another clinical study of an investigational drug or device that has not met its primary endpoint