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

Coronary Artery Disease Clinical Trial

— DCB-MVD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06104033
• Other study ID #: 2306-138-1440
• Status: Recruiting
• Start date: September 18, 2023
• Est. completion date: October 31, 2026

Study information

• Verified date: October 2023
• Source: Seoul National University Hospital
• Contact: Bon-Kwon Koo, MD, PhD
• Phone: +82-2-2072-2062
• Email: bkkoo[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 31, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Multi Vessel Coronary Artery Disease
• Myocardial Ischemia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Bon-Kwon Koo	Seoul

Sponsors (34)

Lead Sponsor

Collaborator

Bon-Kwon Koo

Ajou University School of Medicine, Bucheon Sejong Hospital, Chonnam National University Hospital, Chosun University Hospital, Chung-Ang University Gwangmyeong Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Daegu Catholic University Medical Center, Ewha Womans University Mokdong Hospital, Gachon University Gil Medical Center, Gangnam Severance Hospital, Gyeongsang National University Hospital, Hanyang University Seoul Hospital, Inje University, Inje University Ilsan Paik Hospital, Jeju National University Hospital, KangWon National University Hospital, Keimyung University Dongsan Medical Center, Korea University Anam Hospital, Kyung Hee University Hospital at Gangdong, Kyunghee University Medical Center, Kyungpook National University Hospital, Seoul National University Bundang Hospital, Seoul National University Hospital, Seoul St. Mary's Hospital, Severance Hospital, Soonchunhyang University Hospital, St Vincent's Hospital, Uijeongbu Eulji Medical Center, Eulji University, Uijeongbu St. Mary Hospital, Ulsan Medical Center, Ulsan University Hospital, Wonju Severance Christian Hospital, Yeungnam University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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