Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions

Prior treatment

• Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents

Other illness

• Patients with angiographic findings of 1) Left main coronary artery disease 2) In-stent restenosis is the cause of target lesion 3) Target lesion in bypass graft 4) True bifurcation lesion that requires upfront 2-stenting
• Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year
• Patients with cardiogenic shock or cardiac arrest
• Patients with severe valvular heart disease requiring open heart surgery

Lab values

• Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%)

Other

• Patients unable to provide consent
• Patients who may result in protocol non-compliance (site investigator's medical judgment)
• Pregnant or lactating women

• Subject must be at least 19 years of age
• Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily
• Patients with at least one lesion with greater than 50% diameter stenosis or fractional flow reserve ≤0.80 requiring revascularization in de-novo coronary artery of reference vessel size ≥3.0 mm