The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)

Prior treatment

• Prior coronary artery bypass grafting (CABG) or planned CABG

Other illness

• Active bleeding or coagulopathy
• New York Heart Association (NYHA) class \> II
• Relevant allergies (aspirin, clopidogrel, ticagrelor, contrast compounds, everolimus).
  • Angiographic exclusion criteria:

Lab values

• Renal failure with glomerular filtration rate (GFR) \<50 mL/min per 1.73 m2
• Ejection fraction \< 30%

Age

• Life expectancy \< 2 years

Other

• STEMI within 72 hours
• Cardiogenic shock
• Severe tortuosity around target bifurcation
• Chronic total occlusions
• Massive thrombus in Left main coronary artery
• Medina 0.0.1 lesions

• Stable angina pectoris, unstable angina pectoris, clinically stable non-STEMI.
• Age ≥18 yrs.
• Abel to provide written Informed consent and willing to comply with the specified follow-up contacts.
  • Angiographic inclusion criteria:
• Native coronary bifurcation de novo lesion
• More than 50% diameter stenosis in the main vessel (MV)
• More than 50% diameter stenosis in the side branch (SB) within 5 mm of the ostium.
• Reference size at least 2.75 mm in the main vessel (MV) and ≥2.5 mm in the SB.
  • Functional inclusion criteria:
  • Functional significance of the main vessel lesion or documented ischemia of the main vessel territory or other objective documentation of lesion significance. Objective evidence of ischemia is required for all treated lesions except for lesions with more than 80% diameter stenosis that may be considered significant.
  • Procedural inclusion criteria:
  • Indication for two-stent technique or one-stent technique with kissing balloon inflation