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Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease | Clinical Trials | Clareo Health

RECRUITING

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

NCT06104033•Bon-Kwon Koo

View on ClinicalTrials.gov

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

Age

19 - 100 years

Sex

ALL

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

Locations (1)

Bon-Kwon Koo

Seoul, South Korea

Key Dates

Start Date

September 18, 2023

Primary Completion Date

August 31, 2025

Completion Date

October 31, 2026

Last Updated

October 27, 2023

Enrollment

500

ESTIMATED participants

Conditions

Coronary Artery DiseaseMulti Vessel Coronary Artery Disease

Interventions

drug-coated balloon

DEVICE

drug-eluting stent

DEVICE

Contacts

Bon-Kwon Koo, MD, PhD

CONTACT

+82-2-2072-2062 bkkoo@snu.ac.kr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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