Investigation to Assess the Effects of Drug-COATED Balloons for Treatment of Plaques Erosions Causing Acute Coronary Syndromes (DCB-PE)

Inclusion Criteria:

1. Patients aged ≥18 years presenting with MI where the culprit de-novo (stent restenosis/thrombosis excluded) lesion has a Thrombolysis in Myocardial Infarction (TIMI) flow of ≥ I with signs of thrombus on angiographic (or CCTA followed by conventional coronary angiography) evaluation located in a native coronary artery (a by-pass graft vessel excluded) addressable by PCI;

2. OCT criteria (all 4 should be present):

   1. Presence of thrombus
   2. Absence of an overt ruptured plaque flap
   3. Area of stenosis of ≥ 50%
   4. Presence of atherosclerotic, predominantly lipidic or fibrotic plaque underneath (absence of major calcifications or calcified noduli)

Exclusion Criteria:

1. Culprit lesion located or extending in the Left Main coronary artery;
2. Presence of large coronary aneurysms;
3. Large thrombus burden (extending for more than > 15 mm);
4. Patients with severe tortuous lesions (OCT judged not possible);
5. Spontaneous coronary dissection is suspected;
6. Renal insufficiency (Glomerular Filtration Rate (GFR) < 29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5);
7. Life expectancy less than 2 years;
8. Pregnant or lactating women;
9. Patients currently participating in another trial;

10. Patients that are unable or unwilling to provide consent;

    OCT exclusion criteria:

11. Overt plaque rupture;
12. Thrombosed protruding calcified noduli;
13. Predominantly calcific lesions with calcium arc > 180° in the target segment;
14. Presence of calcium plaque of > 0.4 mm thick;