FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo CAD: the ENCORE-I Study

Inclusion Criteria: * 18 years or older * Stable angina, unstable angina or documented silent ischemia (invasive or non-invasive test) or non-ST segment elevation acute myocardial infarction. * De-novo non-complex coronary obstructive lesions (\>50% stenosis as assessed by quantitative coronary analysis (QCA)) * The patient is willing and able to comply with the specified follow-up evaluations. * Reference vessel diameter (RVD) ≥ 2.5 mm and ≤ 4.0 mm by QCA. * During pre-dilatation, the pre-dilatation balloon is uniformly expanded to the full intended diameter. * Target segment suitable for OCT imaging Exclusion Criteria: * Target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow 0 or 1. * Target lesion located within 5.0 mm of vessel origin. * Lesion type ACC/AHA C. * Heavily calcified lesion * Severe tortuosity * Target lesion is located in or supplied by an arterial or venous bypass graft. * Target lesion requires treatment with a device other than the pre-dilatation balloon prior to scaffold placement (including but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, etc.). * Unsuccessful pre-dilatation, defined as a residual diameter stenosis ≥ 30%, assessed by QCA. * Planned future revascularization of non-culprit lesions. * Presence of another device (stent or scaffold) located within the same segment (5mm from the target lesion borders). * Patient is currently participating in another study with an investigational device or an investigational drug and has not completed the entire follow-up period. * Impaired renal function (eGFR \<30ml/min). * Patient has a contraindication for the use of double antiplatelet therapy for at least 12 months. * Pregnant or breastfeeding patients. * Patient has a known allergy to contrast medium, sirolimus, Tyrosine-derived polycarbonate or other structurally related compounds. * Patient is receiving chronic oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease (diabetes mellitus is not an exclusion criteria). * Patient has a co-morbidity, which reduces life expectancy to ≤ 24 months, or social-economic factors making compliance with the study requirements difficult.