Coronary Intervention Using the CardioMind Coronary Stent System for the treatment of stenotic lesions in small diameter native coronary arteries

INTERVENTION: The study will randomize 230 patients with de novo lesions in native coronary arteries with a reference diameter of 2.0 – 2.75 mm. The 3 treatment arms include the CardioMind sirolimus‐eluting stent, the CardioMind bare metal stent, and the Medtronic Micro‐Driver bare metal stent. Clinical follow‐up will occur at 30 days, 8, 12 and 24 months. Telephone follow‐up will occur at 6 months and years 3‐5. Data will be compared among treatment groups. CONDITION: Coronary artery disease PRIMARY OUTCOME: In‐stent late lumen loss by quantitative coronary angiography (QCA) SECONDARY OUTCOME: 2D & 3D Intravascular Ultrasound (sub‐set of patients) Clinically driven target lesion revascularization, target vessel revascularization or target vessel failure Device, Lesion, Procedure Success In‐segment late lumen loss In‐stent and in‐segment binary restenosis, minimum lumen diameter and % diameter stenosis Major adverse cardiac events Major vascular complications Stent thrombosis INCLUSION CRITERIA: Suitable candidate for percutaneous coronary intervention (PCI) in a symptomatic native coronary vessel with a reference diameter of 2.0 – 2.75 mm and lesion length < 20 mm. Treatment of one non‐target lesion in a separate epicardial vessel is allowed.