About this trial
This study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).
Eligibility criteria
Qualifiers
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
Disqualifiers
Patients unable to provide consent
Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
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
Trial design
Treatments tested in this trial
- Drug-eluting stent implantation
- Drug-coated balloon angioplasty
Treatment groups
Sponsors and collaborators
Chonnam National University Hospital
Lead sponsor
Boston Scientific Corporation
Collaborator