Microvascular Obstruction Diagnosis Using the CoFI™ System Assessment - II

Prior treatment

• Cardiac condition mandating elective PCI/CABG procedure prior to CMRI

Other illness

• Unsuitable target vessel anatomy (excessive tortuosity, diffuse disease, or moderate/heavy calcification)
• Cardiac condition preventing the use of the CoFI System
• Any angiographic post stenting condition that according to the physician implies soc administration of any GpIIb/IIIa inhibitors or adenosine

Lab values

• Clinical:
  • Cardiogenic shock
  • Thrombolytic therapy administered for this STEMI
  • Contraindication to CMRI
  • Cardiac pacemaker or implantable defibrillator;
  • Non-MRI compatible aneurysm clip;
  • Neural Stimulator (i.e., TENS unit);
  • Any implanted or magnetically activated device (insulin pump);
  • Any type of non-MRI compatible ear implant;
  • Metal shavings in the orbits;
  • Any metallic foreign body, shrapnel, or bullet in a location which the physician feels would present a risk to the subject;
  • Any history indicating contraindication to MRI
  • Inability to follow breath hold instructions or to maintain a breath hold for \>15 seconds; and
  • Known hypersensitivity or contraindication to gadolinium contrast.
  • Subject with previous MI and/or known cardiomyopathy (ischemic and non ischemic), ventricular pseudoaneurysm, VSD, severe mitral valve regurgitation (with or without papillary muscle rupture), severe known cardiac valvular stenosis or insufficiency, pericardial disease
  • Major bleeding ≤ 30d prior to intervention
  • Major surgery ≤ 30d prior to intervention
  • TIA or stroke ≤ 30d prior to intervention
  • Heart failure with inotrope support and/or consideration for LVAD or heart transplant
  • Known severe renal disease with creatinine \> 2.5 mg/dL and/or eGFR \< 30 mL/min/1.73 m2
  • Subject has other medical illness (e.g., cancer, dementia) or known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause non-compliance with the CIP, confound the data interpretation, or is associated with limited life expectancy of less than one year
  • Current participation in another clinical study
  • Pregnancy
  • PPCI \& Angiographic:

Other

• CABG of LAD

• Clinical:
  • Subject ≥18 years of age
  • Ability to provide written informed consent according to GCP and governing regulations
  • Diagnosis of acute anterior STEMI
  • Persistent symptoms to balloon time ≤ 6 hours. The assessment by the treating investigator after evaluation by subjects explanation is the defining timepoint for symptom onset.
  • PPCI \& Angiographic
• Culprit lesion in the LAD
• COFI ballon can be placed according to IFU
• Required stent diameter ≥ 2.75 mm and ≤ 5mm
• Required stent length ≥ 15 mm
• Successful PPCI Procedure as documented by \<50% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow.