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

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

Recruiting
19 years and older
All
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  1. Age 19 or older
  2. 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
  3. Capable of understanding the risks and benefits of participating in the study and

    providing informed consent

Exclusion Criteria:

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

Study details
    Coronary Artery Disease
    Multi Vessel Coronary Artery Disease

NCT06104033

Bon-Kwon Koo

27 January 2024

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