Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction
Denmark, France145 participantsStarted 2019-07-25
Plain-language summary
The objective of this study is to assess efficacy and safety of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy started post flow restoration but prior to stenting during percutaneous coronary intervention (PCI) compared to standard PCI in the setting of acute ST-segment elevation anterior myocardial infarction (STEMI).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years old
✓. Culprit lesion in proximal or mid LAD
✓. Pre-PCI TIMI flow 0 or 1.
✓. Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h.
✓. 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
✓. Patient is deemed eligible for primary PCI
✓. STEMI patients: consent as per approved national ethical committee specific requirements prior to the procedure.
Exclusion criteria
✕. Implants or foreign bodies in the coronary sinus
✕. Known allergy to polyurethanes, PET or stainless steel
✕. Known pregnancy and breastfeeding
✕. Pericardial effusion (cardiac tamponade)
✕. Central hemodynamically relevant left/right shunt