DCB vs. DES in Bifurcation Coronary Lesions

Inclusion criteria

• Subject must be age ≥18 years.
• Subject has silent ischemia, or stable/unstable angina, or acute MI older than 1-week from the onset of chest pain to admission.
• Subject understands the trial design and treatment procedures and provides written informal consent before entering the trial
• Subject is willing to comply with all protocol-required follow-up evaluations.
• Target lesion must be native non-LM bifurcation lesion
• Target lesion must be a bifurcation lesion on coronary angiography (defined as Medina 0,1,1, Medina 1,0,1, Medina 1,1,1 or Medina 0,0,1 coronary bifurcation lesions) and is eligible for percutaneous coronary intervention (PCI).
• Target lesion reference vessel diameter (both main vessel and side branch)

• 2.0 mm by visual estimation.
• Target lesion must have visually estimated stenosis ≥50%.
• Target lesion length of side branch must be <25 mm by visual estimation.

Exclusion criteria

• Patient with STEMI (within 3 days from the onset of chest pain to coronarography).
• Patient has known allergy to the study balloon/stent system.
• Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.
• Patient is pregnant or nursing.
• Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure.
• Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.
• In-stent restenosis lesion.
• Chronic total occlusion (CTO) lesion in either main vessel or side branch.
• Left ventricular ejection fraction <30%;
• Visible and untreatable thrombus at lesion site;
• Target lesion/vessel with any of the following characteristics:

• Severe and/or >270° calcification of the target vessel, also proximal to the lesion (intravascular imaging);
• Bifurcation lesion where stent strategy is anticipated;
• Left main stem stenosis >50%;
• Target lesion is in the left main stem;
• Lesions length >50 mm (main vessel)
• Lesions length >25 mm (side branch)