MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction

Inclusion criteria

Clinical:

• At least 18 years of age.
• ST-segment elevation Myocardial Infarction documented in an ambulance or in a Cathlab, with ≥2 mm ST segment elevation in at least two contiguous leads, presenting in the Cathlab <12 hours after the onset of symptoms lasting ≥20 min requiring primary PCI.
• Target lesion must be a de-novo lesion located in a native vessel.
• The patient accepts Informed Consent
• The patient understands and accepts clinical follow-up and angiographic control.

Angiographic:

• Vessel size should match available M-BRS scaffold sizes (≥2.75 mm, and ≤3.7 mm by visual assessment).
• Lesion preparation by either manual thrombectomy or pre-dilatation has been successful, with opening of the vessel and TIMI ≥2 and residual stenosis <20%.

Exclusion criteria

• Pregnancy.
• Known intolerance to aspirin, heparin, stainless steel, sirolimus, and contrast material.
• Distal vessel occlusion after recanalization
• STEMI due to stent/scaffold thrombosis
• Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal m-BRS placement.
• Fibrinolysis prior to PCI
• Known thrombocytopenia (PLT< 100,000/mm3)
• Active bleeding or coagulopathy or patients at chronic anticoagulation therapy
• Cardiogenic Shock
• Significant comorbidities precluding clinical/angiographic FU (as judged by investigators)
• Major planned surgery that requires discontinuation of dual antiplatelet therapy.
• Diffuse coronary artery disease that will require CABG
• Chronic kidney disease with GFR<30 ml/min