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

Inclusion criteria

• 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;
• OCT criteria (all 4 should be present):

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

Exclusion criteria

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

OCT exclusion criteria:

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