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

RecruitingNAAges 19 Years - anyAllChonnam National University Hospital
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In plain words

What the trial is, and whether it could suit you

This study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria 1. Subject must be at least 19 years of age 2. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily 3. Patients with at least one lesion with greater than 50% diameter stenosis or fractional flow reserve โ‰ค0.80 requiring revascularization in de-novo coronary artery of reference vessel size โ‰ฅ3.0 mm Exclusion Criteria 1. Patients unable to provide consent 2. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents 3. 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 4. Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year 5. Patients who may result in protocol non-compliance (site investigator's medical judgment) 6. Patients with cardiogenic shock or cardiac arrest 7. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%) 8. Patients with severe valvular heart disease requiring open heart surgery 9. Pregnant or lactating women
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What it tests

  • Drug-eluting stent implantation
  • Drug-coated balloon angioplasty
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Where

8 sites
Kosin University Gospel Hospital
Busan, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Chonnam National University
Gwangju, South Korea
Jeonbuk National University Hospital
Jeonju, South Korea
Samsung Medical Center
Seoul, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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