Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease

Обзор

This study is a prospective, multicenter, open-label, observational study to investigate the impact of using drug-coated balloons (DCBs) in the treatment of coronary artery lesions in patients with multivessel coronary artery disease (MVD), as opposed to the default strategy of using only drug-eluting stents (DES). The investigators aim to assess changes in clinical practice towards a hybrid treatment strategy (DES and DCB) and its effects on clinical outcomes.

Вмешательства

• Устройство drug-coated balloon
  For the procedure, the drug-coated balloon (Agent®, Boston Scientific, USA) that can be used for both de-novo coronary lesions and in-stent restenosis lesions is used.
• Устройство drug-eluting stent
  When using drug-eluting stents, the latest 2nd generation drug-eluting stent (Synergy®, Boston Scientific, USA) should be used in accordance with the latest guidelines.

Первичные конечные точки

• The reclassification rate of the treatment strategy [Срок оценки: At the time of procedure]

Вторичные конечные точки (12)

• Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy [Срок оценки: At the time of procedure]
• Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy [Срок оценки: At the time of procedure]
• Cardiovascular death [Срок оценки: 1 year]
• All-cause death [Срок оценки: 1 year]
• Non-fatal myocardial infarction (MI) [Срок оценки: 1 year]
• Target vessel MI excluding periprocedural MI [Срок оценки: 1 year]
• Target vessel MI including periprocedural MI [Срок оценки: 1 year]
• Clinically indicated target lesion revascularization [Срок оценки: 1 year]
• Clinically indicated target vessel revascularization [Срок оценки: 1 year]
• Any revascularization [Срок оценки: 1 year]
• Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition [Срок оценки: 1 year]
• Cardiovascular death or target vessel MI [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Age 19 or older
• Multivessel coronary artery disease patients requiring coronary intervention

• Stenosis of 2 or more major coronary arteries or major coronary artery branches (Vessel size ≥2.5mm) with diameter stenosis ≥50% or fractional flow reserve ≤0.80 requiring repeat revascularization
• Having stenotic lesions requiring revascularization with a vessel size of 2.5mm to 3.0mm
• Capable of understanding the risks and benefits of participating in the study and providing informed consent

Критерии исключения

• Incapable of voluntarily providing informed consent
• Allergy or contraindication to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
• Cardiogenic shock or cardiac arrest patients
• Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
• Patients for whom coronary artery bypass surgery is prioritized over coronary artery intervention
• Patients with severe valvular heart disease requiring open heart surgery
• Pregnant or lactating women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 1 центр

• Bon-Kwon Koo — Seoul

Идентификаторы

NCT: NCT06104033 · 2306-138-1440

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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