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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06104033

Acronym

DCB-MVD

Enrollment

500

Registered

2023-10-27

Start date

2023-09-18

Completion date

2026-10-31

Last updated

2023-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Multi Vessel Coronary Artery Disease

Keywords

Coronary artery disease, Multivessel coronary artery disease, Percutaneous coronary intervention, Drug-coated balloon, Drug-eluting stent

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 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.

Interventions

DEVICEdrug-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.

DEVICEdrug-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 design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 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

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Countries

South Korea

Contacts

Primary ContactBon-Kwon Koo, MD, PhD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Measure	Time frame	Description
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy	At the time of procedure	Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy	At the time of procedure	Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy
Cardiovascular death	1 year	Cardiovascular death
All-cause death	1 year	All-cause death
Non-fatal myocardial infarction (MI)	1 year	Non-fatal myocardial infarction (MI)
Target vessel MI excluding periprocedural MI	1 year	Target vessel MI excluding periprocedural MI
Target vessel MI including periprocedural MI	1 year	Target vessel MI including periprocedural MI
Clinically indicated target lesion revascularization	1 year	Clinically indicated target lesion revascularization
All-cause death or non-fatal MI	1 year	All-cause death or non-fatal MI
Any revascularization	1 year	Any revascularization
Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition	1 year	Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition
Cardiovascular death or target vessel MI	1 year	Cardiovascular death or target vessel MI
Target vessel failure (TVF), including cardiovascular death, target vessel MI, or clinically indicated target vessel revascularization	1 year	Target vessel failure (TVF), including cardiovascular death, target vessel MI, or clinically indicated target vessel revascularization
Target lesion failure (TLF), including cardiovascular death, target lesion MI, or clinically indicated target lesion revascularization	1 year	Target lesion failure (TLF), including cardiovascular death, target lesion MI, or clinically indicated target lesion revascularization
Cardiovascular death, target vessel MI, or vessel or stent thrombosis	1 year	Cardiovascular death, target vessel MI, or vessel or stent thrombosis
All-cause death, non-fatal MI, or clinically indicated target vessel revascularization	1 year	All-cause death, non-fatal MI, or clinically indicated target vessel revascularization
Major bleeding events (BARC type 2, 3, or 5)	1 year	Major bleeding events (BARC type 2, 3, or 5)
Clinically indicated target vessel revascularization	1 year	Clinically indicated target vessel revascularization