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

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 has a co-morbidity, which reduces life expectancy to ≤ 24 months, or social-economic factors making compliance with the study requirements difficult.