Status:
RECRUITING
Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease
Lead Sponsor:
Bon-Kwon Koo
Collaborating Sponsors:
Seoul National University Hospital
St Vincent's Hospital
Conditions:
Coronary Artery Disease
Multi Vessel Coronary Artery Disease
Eligibility:
All Genders
19-100 years
Brief Summary
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 mu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 18 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06104033
Start Date
September 18 2023
End Date
October 31 2026
Last Update
October 27 2023
Active Locations (1)
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1
Bon-Kwon Koo
Seoul, South Korea