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โ† Trials
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Smart Angioplasty Research Team-Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion With Drug-Coated Balloon

RecruitingNAAges 19 Years - anyAllSamsung Medical Center
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In plain words

What the trial is, and whether it could suit you

A prospective, multi-center, open-label, randomized controlled, superiority trial. The aim of the study is to compare clinical outcomes between upfront 2-stenting strategy versus upfront drug-coated balloon (DCB)-based hybrid strategy in patients with complex coronary bifurcation with clinically relevant side branch lesions.

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

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria * Subject must be at least 19 years of age * Patients with acute or chronic coronary syndrome intended for percutaneous coronary intervention (PCI) * Patients with de novo complex coronary bifurcation with clinically relevant side branch. Definition of complex coronary bifurcation with clinically relevant side branch is true bifurcation lesion (Medina 1,1,1 / 1,0,1 / 0,1,1) with side branch lesion length โ‰ฅ10mm and should meet at least one of the below criteria. i. Left main bifurcation with side branch stenosis severity โ‰ฅ70% by visual estimation ii. Non-left main bifurcation with side branch reference vessel diameter โ‰ฅ2.75mm and stenosis severity โ‰ฅ90% by visual estimation * Subject who can verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive approach and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. Exclusion Criteria * Hemodynamically unstable condition (SBP \<90 mmHg even after administration of vasopressor, ventricular arrhythmias, or cardiogenic shock) * Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock) * Known significant congenital, severe valvular or cardiomyopathic (hypertrophic or dilated cardiomyopathy, or any other forms) process which could explain cardiac symptoms. * Severe left ventricular systolic dysfunction (ejection fraction \<30%) * Intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, or heparin. * Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment) * Unwillingness or inability to comply with the procedures described in this protocol.
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What it tests

  • Upfront DCB-based hybrid strategy
  • Upfront 2-stenting strategy
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Where

3 sites
Chonnam National University Hospital
Gwangju, South Korea
Chosun University Hospital
Gwangju, South Korea
Samsung Medical Center
Seoul, 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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