Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease (DCB-MVD)

Bon-Kwon Koo

Status: Enrolling

Conditions: Coronary Artery Disease; Multi Vessel Coronary Artery Disease

Treatments: Device: drug-eluting stent; Device: drug-coated balloon

Study type: Observational

Funder types: Other

Identifiers

NCT06104033

2306-138-1440

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 19 to 100 years old

Volunteers: No 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

Trial design

500 participants in 2 patient groups

Hybrid strategy

Description:

The patient undergoes percutaneous coronary intervention with drug-coated balloons and drug-eluting stents or drug-coated balloons only in the coronary artery lesion.

Treatment:

Device: drug-coated balloon

Device: drug-eluting stent

DES only

Description:

The patient undergoes percutaneous coronary intervention with drug-eluting stents only in the coronary artery lesion.

Treatment:

Device: drug-eluting stent