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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorChonnam National University Hospital

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

256 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Chonnam National University Hospital

Lead sponsor

Boston Scientific Corporation

Collaborator