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. 2021 Mar 19;16(16):1333–1341. doi: 10.4244/EIJ-D-18-00902

Table 1. Inclusion criteria.

Clinical inclusion criteria
1 Subject has coronary artery disease involving a bifurcation with objective evidence of ischaemia including patients with chronic stable angina, silent ischaemia and NSTE-ACS
2 Subject is appropriate to be treated by PCI according to the local practice (operator’s judgement or Heart Team decision)
3 Patient is at least 18 years of age
4 Signed informed consent
5 The patient understands and accepts clinical follow-up and OFDI controls
6 Patient’s residence is in the area covered by the hospital
Angiographic inclusion criteria
1 Patients with angiographically significant stenosis (>50% by visual assessment) in de novo, native, previously unstented bifurcation lesion(s) including left main lesion, which is in the operator’s opinion appropriate to be treated by PCI with a single-stent strategy
2 The size of main vessel matches available Ultimaster stent sizes (<4.0 mm, and >2.0 mm by visual assessment)
3 The size of side branch is >2.0 mm in diameter by visual assessment
4 The side branch is treatable with a side branch fenestration and/or kissing balloon
NSTE-ACS: non-ST-elevation acute coronary syndrome; OFDI: optical frequency domain imaging; PCI: percutaneous coronary intervention