Randomised EValuation of Therapies for microvAscuLar Injury in STEACS

Prior treatment

• Subject with previous MI and/or known cardiomyopathy (ischemic and non ischemic), ventricular pseudoaneurysm, ventricular Septal defect, severe mitral valve regurgitation (with or without papillary muscle rupture), severe known cardiac valvular stenosis or regurgitation, pericardial disease
• Major bleeding ≤ 30d prior to intervention defined according to BARC 3-5
• Major surgery ≤ 30d prior to intervention
• Treatment with oral anticoagulation therapy

Other illness

• Mental disorder or language barrier that precludes informed assent/consent GCP, governing regulations and approved process
• Pericardial effusion (cardiac tamponade)
• History of stroke, TIA or reversible ischemic neurological deficit within last 6 months
• Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 min
• Heart failure with inotrope support and/or consideration for LVAD or heart transplant
• 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
• 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.
  • PPCI and Angiographic criteria 19. Functional coronary collateral supply (Rentrop grade 2/3) to the infarct-related artery 20. Unsuitable target vessel anatomy (excessive tortuosity, diffuse disease, or moderate/heavy calcification) preventing successful wiring with pressure wire 21. Cardiac condition preventing the use of the CoFI System 22. Any pre or post stenting condition that the physician believes requires a pharmacological iv or ic drug administration for a cardiac related condition to be administered before or during stenting, apart from standard of care administration of anaesthetics, heparin, nitrates or verapamil

Lab values

• Known severe kidney disease (estimated glomerular filtration rate (eGFR) \< 30 ml/min) or on haemodialysis
• Cardiogenic shock and/or persistence of cardiogenic shock at completion of primary PCI. Cardiogenic shock defined as a. hypotension (systolic blood pressure below 100 mm Hg or an ongoing need for vasopressor support), and b. end-organ hypoperfusion with an arterial lactate level of 2.5 mmol/L or greater

Other

• CLINICAL criteria
• Unconscious on presentation
• Patients under judicial protection, legal guardianship or curatorship
• Known coagulopathy
• Need for circulatory support or pre/intra-procedural ventilation
• Current participation in another clinical study
• Known Pregnancy or breast feeding
  • If CMRI substudy to be confirmed at the time of consent to the substudy:

• CLINICAL criteria
• Subjects age ≥18 years old
• Ability to provide informed assent/consent to the study according to GCP, governing regulations and approved process
• Infarct-related lesion in proximal or mid left anterior descending coronary artery
• ECG evidence of acute anterior myocardial infarction with ST-elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial ECG leads (one of which should be V2, V3, or V4) in men or ≥ 1.5 mm (0.15 mV) in women
• Symptoms onset to balloon time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 6 h
• Suitability for Primary PCI
  • PPCI and Angiographic
• Culprit lesion in the LAD that is suitable for stenting
• COFI ballon can be placed according to IFU
• Required stent diameter ≥ 2.75 mm and ≤ 5mm and stent length ≥ 15 mm