Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease
Bon-Kwon Koo
500 participants
Sep 18, 2023
OBSERVATIONAL
Conditions
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 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 Criteria5
- 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 Criteria7
- 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
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Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06104033