Clinical inclusion criteria:
Subject must be male or non-pregnant female ≥18 years of age and ≤75 years of age; Subject has symptomatic coronary artery disease with objective evidence of ischaemia or silent ischaemia; Subject is eligible for PCI; Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed; Subject is willing to comply with all protocol-required follow-up evaluation.
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Clinical exclusion criteria:
Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (eg, stent alloy, stainless steel, sirolimus, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors or aspirin); Planned surgery within 6 months after the index procedure; -
Subject has one of the following (as assessed prior to the index procedure):
Other serious medical illness (eg, cancer, congestive heart failure) with estimated life expectancy of less than 12 months; Current problems with substance abuse (eg, alcohol, cocaine and heroin); Planned procedure that may cause non-compliance with the protocol or confound data interpretation.
Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions; Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint; Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure; Subject with known intention to procreate within 12 months after the index procedure (women of childbearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure); Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of childbearing potential); Subject with left ventricular ejection fraction <35%; Subject has preoperative renal dysfunction: serum creatinine >2.0 mg/dL (176.82 μmol/L).
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Angiographic inclusion criteria:
Subjects have coronary bifurcation lesions requiring PCI with stent implantation according to clinical guidelines and/or the operator’s judgement; Visually estimated reference vessel diameter (RVD) of target main vessel ≥2.5 mm and ≤4.0 mm; Visually estimated RVD of target side branch ≥2.0 mm; Coronary anatomy is likely to allow delivery of a study device to the target lesion(s); V-RESOLVE score ≥12 points.
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Angiographic exclusion criteria:
Left main lesions; In case of acute myocardial infarction (MI) of which the culprit vessel located at the left anterior descending coronary artery (LAD), the bifurcation lesion (LAD/diagonal branch (RVD >2.5 mm)), which is proximal to occluded LAD segment, should be excluded.
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