Table 1

Inclusion and exclusion criteria

Inclusion criteriaExclusion criteria
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.

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).

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.

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.

  • PCI, percutaneous coronary intervention.