ID.1
Item
subject has provided a written informed consent
boolean
ID.2
Item
single de novo lesion with ≥ 50% and <100% stenosis in up to 2 coronary arteries
boolean
ID.3
Item
the target lesion length is ≤ 26 mm
boolean
ID.4
Item
the target reference vessel diameter is ≥ 2.0 mm and ≤ 4.0 mm
boolean
ID.5
Item
main exclusion criteria:
boolean
ID.6
Item
evidence of myocardial infarction within 72 hours prior to index procedure
boolean
ID.7
Item
unprotected left main coronary artery disease (stenosis >50%)
boolean
ID.8
Item
three-vessel coronary artery disease at time of procedure thrombus in target vessel
boolean
ID.9
Item
target lesion involves a side branch > 2.0 mm in diameter
boolean
ID.10
Item
heavily calcified lesion
boolean
ID.11
Item
target lesion is located in or supplied by an arterial or venous bypass graft
boolean