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

• PCI with size matched DCB (Device): Subjects will be treated with PCI with size matched DCB (SeQuent)
• GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy (Drug): GP IIbIIIa inhibitor or heparin \& dual antiplatelet therapy

Primary outcomes

• Optical Coherence Tomography (OCT)-assessed Minimum Lumen Area (MLA) during the control procedure [Day 2-3]

Secondary outcomes

• Coronary Computed Tomography Angiography (CCTA) assessed MLA at 1-year [1 Year]
• Target Lesion Failure (TLF) at 1-year [1 Year]: TLF is defined as Cardiac death, Target Vessel-MI (TV-MI), and Clinically-Driven Target Lesion Revascularization (CD-TLR)
• TLF at 2-years [2 Years]: TLF is defined as Cardiac death, TV-MI, and CD-TLR

Other outcomes

• CCTA-assessed plaque burden at baseline [Baseline]
• CCTA-assessed plaque burden post PCI [1 Week]
• CCTA-assessed plaque burden at 1-year [1 Year]
• CCTA-assessed lipid pool volume at baseline [Baseline]
• CCTA-assessed lipid pool volume post PCI [1 Week]
• CCTA-assessed lipid pool volume at 1-year [1 Year]
• Computed Tomography Fractionated Flow Reserve (CT-FFR) at baseline [Baseline]
• CT-FFR at 1-year [1 Year]
• Shear stress at lesion level at baseline measured by Elucid software [Baseline]
• Shear stress at lesion level at 1-year measured by Elucid software [1 Year]
• OCT-assessed thrombus volume at baseline [Baseline]
• OCT-assessed thrombus volume at control procedure [Day 2-3]
• OCT-assessed area of stenosis post index procedure [Periprocedural]
• OCT-assessed area of stenosis post control procedure [Day 2-3]
• OCT-assessed lumen gain [Periprocedural and Day 2-3]: Difference between control and index MLA
• OCT-assessed lipid arc at control procedure [Day 2-3]

Sex: All, ages: 18 Years to any

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;