A Study to Evaluate Safety and Feasibility of PiCSO Therapy in Patients With ST Elevation Inferior Wall Myocardial Infarction. (PiCSO-AMI-V)

This is an interventional treatment trial for STEMI - ST Elevation Myocardial Infarction focused on measuring PiCSO, PiCSO Impulse System Read More

Inclusion Criteria:

1. Age ≥18 years old
2. Right dominance with culprit lesion in mid or proximal RCA
3. Pre-PCI TIMI flow 0 or 1 in the culprit lesion
4. Symptom onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h
5. ECG evidence of acute inferior myocardial infarction with ST-elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous inferior precordial ECG leads (II, III, AVF) in men or ≥ 1.5 mm (0.15 mV) in women
6. Emergent PCI will be performed according to national and local hospital guidelines
7. Consent per approved national EC specific requirements prior to the procedure.

Exclusion Criteria:

1. Patient transferred from an outside hospital where invasive coronary procedure was attempted (including diagnostic catheterization)
2. Implants or foreign bodies in the coronary sinus
3. Left main disease >= 50%
4. Large left anterior descending artery providing blood supply beyond the left ventricular apex (supplying part of the inferior wall) as judged by angiography.
5. Known allergy to polyurethanes, PET or stainless steel, both heparin and bivalirudin, or all of clopidogrel, ticagrelor or prasugrel that cannot be adequately premedicated
6. Known pregnancy or breastfeeding
7. Known large pericardial effusion or cardiac tamponade
8. Known hemodynamically relevant left to right and right to left shunt
9. Previous CABG
10. Known neurologic abnormality such as tumor or AV malformation, history of stroke within 6 months, any prior intracranial bleed or any permanent neurologic defect
11. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), any recent GU or GI bleed (within 3 months)
12. Administration of fibrinolytic therapy within 24 hours prior to enrollment
13. Cardiogenic shock (SBP < 90 mmHg), need for mechanical circulatory support, intravenous pressor or pre-randomization intubation
14. Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 min or whom baseline neurologic status is not present
15. Patient not suitable for femoral vein access
16. Active participation in another drug or device investigational study that has not reached its primary endpoint
17. Known severe kidney disease (eGFR <=30 mL/min/1.73 m2 by MDRD formula) or on hemodialysis
18. COPD with home oxygen therapy or on chronic steroid therapy for COPD
19. Unconscious on presentation
20. Patients under judicial protection, legal guardianship or curatorship
21. Patient 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 protocol, confound the data interpretation, or is associated with limited life expectancy of less than 1 year
22. Patients with definite or probable COVID-19 diagnosis > 4 weeks prior to the current MI unless they had returned to their baseline state of health after recovery from the COVID-19 illness
23. Any evidence of active infectious disease, or definite or probable COVID-19 diagnosis within the prior 4 weeks.