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

Recruiting

• Conditions: Coronary Artery Disease; Multi Vessel Coronary Artery Disease
• Interventions: Device: drug-coated balloon; Device: drug-eluting stent

• Registration Number: NCT06104033
• Lead Sponsor: Bon-Kwon Koo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-18
• Status Verified: 2023-10
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Last Update Submitted: 2023-10-23
• Study First Posted: 2023-10-27
• Last Update Posted: 2023-10-27
• Primary Completion: 2025-08-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hybrid strategy	drug-coated balloon	The patient undergoes percutaneous coronary intervention with drug-coated balloons and drug-eluting stents or drug-coated balloons only in the coronary artery lesion.
DES only	drug-eluting stent	The patient undergoes percutaneous coronary intervention with drug-eluting stents only in the coronary artery lesion.
Hybrid strategy	drug-eluting stent	The patient undergoes percutaneous coronary intervention with drug-coated balloons and drug-eluting stents or drug-coated balloons only in the coronary artery lesion.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Cardiovascular death or target vessel MI	1 year	Cardiovascular death or target vessel MI
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
Target vessel MI excluding periprocedural MI	1 year	Target vessel MI excluding periprocedural MI
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
All-cause death	1 year	All-cause death
Target vessel MI including periprocedural MI	1 year	Target vessel MI including periprocedural MI
Cardiovascular death	1 year	Cardiovascular death
Non-fatal myocardial infarction (MI)	1 year	Non-fatal myocardial infarction (MI)
Clinically indicated target vessel revascularization	1 year	Clinically indicated target vessel 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
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
Any revascularization	1 year	Any revascularization
Cardiovascular death, target vessel MI, or vessel or stent thrombosis	1 year	Cardiovascular death, target vessel MI, or vessel or stent thrombosis
Major bleeding events (BARC type 2, 3, or 5)	1 year	Major bleeding events (BARC type 2, 3, or 5)
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
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
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

Trial Locations

Locations (1)

Bon-Kwon Koo; 🇰🇷 Seoul, Korea, Republic of