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

NCT06104033 · tracked via the Priya Life Science South Korea tracker

Sponsor

Bon-Kwon Koo

Phase

Observational

Started

2023-09-18

Last updated

2023-10-27

Condition(s) studied

Coronary Artery DiseaseMulti Vessel Coronary Artery Disease

Investigational drug(s) / intervention(s)

drug-coated balloondrug-eluting stent

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.

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.

Study 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

Sex

ALL

Min age

19 Years

Max age

100 Years

Healthy volunteers

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

Primary outcome measure(s)

The reclassification rate of the treatment strategy — At the time of procedure
The reclassification rate according to the change in treatment approach from the default strategy of using only drug-eluting stents (DES-only) to the hybrid strategy of using both drug-coated balloons and drug-eluting stents in the treatment of multivessel coronary artery disease.

Trial sites (1)

Facility	City	Region	Status
Bon-Kwon Koo	Seoul	South Korea	Recruiting

More Bon-Kwon Koo trials in South Korea

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06104033 on ClinicalTrials.gov ↗ ← All trials in South Korea