A Study to Evaluate the Safety and Efficacy of PiCSO in Anterior STEMI Patients (PiCSO-AMI-II)

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. Culprit lesion in proximal or mid left anterior descending artery (LAD)
3. Pre-PCI TIMI flow 0, 1 or 2
4. Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h
5. Electrocardiogram (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
6. Emergent PCI will be performed according to national and local hospital guidelines
7. Consent per approved national IRB/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. Need for treatment of any vessel other than the LAD (or its branches) during the index procedure or before the 5 ± 2 days study CMR.
5. Known allergy to polyurethanes, polyethylene terephthalate (PET) or stainless steel, both heparin and bivalirudin, or all of clopidogrel, ticagrelor or prasugrel that cannot be adequately pre-medicated
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. Known previous myocardial infraction (MI)
10. Previous coronary artery bypass graft (CABG)
11. Known neurologic abnormality such as tumor or arteriovenous (AV) malformation, history of stroke within 6 months, any prior intracranial bleed or any permanent neurologic defect
12. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), any recent genitourinary (GU) or gastrointestinal (GI) bleed (within 3 months)
13. Administration of fibrinolytic therapy within 24 hours prior to enrollment
14. Cardiogenic shock (systolic blood pressure (SBP) < 90 mmHg), need for mechanical circulatory support, intravenous pressor or pre-randomization intubation
15. Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 min or whom baseline neurologic status is not present
16. Patient not suitable for femoral vein access
17. Contraindication to cardiac magnetic resonance imaging CMR (e.g. claustrophobia, foreign body implants incompatible with CMR, gadolinium intolerance)
18. Active participation in another drug or device investigational study that has not reached its primary endpoint
19. Known severe kidney disease (eGFR <=30 mL/min/1.73 m2 by MDRD formula) or on hemodialysis
20. Chronic obstructive pulmonary disease (COPD) with home oxygen therapy or on chronic steroid therapy
21. Unconscious on presentation
22. Patients under judicial protection, legal guardianship or curatorship
23. 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 protocol, confound the data interpretation, or is associated with limited life expectancy of less than 1 year
24. 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