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

• Sponsor: Bon-Kwon Koo (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06104033
• Collaborator: Seoul National University Hospital (Other), St Vincent's Hospital (Other), Uijeongbu St. Mary Hospital (Other), Gachon University Gil Medical Center (Other), Gangnam Severance Hospital (Other), Kyunghee University Medical Center (Other), Keimyung University Dongsan Medical Center (Other), Inje University Ilsan Paik Hospital (Other), Daegu Catholic University Medical Center (Other), Bucheon Sejong Hospital (Other), Seoul National University Bundang Hospital (Other), Soonchunhyang University Hospital (Other), Yeungnam University Hospital (Other), Wonju Severance Christian Hospital (Other), Ulsan University Hospital (Other), Ewha Womans University Mokdong Hospital (Other), Inje University (Other), Chonnam National University Hospital (Other), Chung-Ang University Gwangmyeong Hospital (Other), Chung-Ang University Hosptial, Chung-Ang University College of Medicine (Other), Ulsan Medical Center (Other), Hanyang University Seoul Hospital (Other), Jeju National University Hospital (Other), KangWon National University Hospital (Other), Uijeongbu Eulji Medical Center, Eulji University (Other), Seoul St. Mary's Hospital (Other), Gyeongsang National University Hospital (Other), Severance Hospital (Other), Chosun University Hospital (Other), Kyungpook National University Hospital (Other), Korea University Anam Hospital (Other), Kyung Hee University Hospital at Gangdong (Other), Ajou University School of Medicine (Other)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 37.4
• Patients Per Site Per Month: 13.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Multi Vessel Coronary Artery Disease	Device: drug-coated balloon; Device: drug-eluting stent

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease
• Actual Study Start Date: Sep 18, 2023
• Anticipated Primary Completion Date: Aug 31, 2025
• Anticipated Study Completion Date: Oct 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Hybrid strategy The patient undergoes percutaneous coronary intervention with drug-coated balloons and drug-eluting stents or drug-coated balloons only in the coronary artery lesion.	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.; Device: 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.
DES only The patient undergoes percutaneous coronary intervention with drug-eluting stents only in the coronary artery lesion.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. Cardiovascular death [1 year]

   Cardiovascular death

4. All-cause death [1 year]

   All-cause death

5. Non-fatal myocardial infarction (MI) [1 year]

   Non-fatal myocardial infarction (MI)

6. Target vessel MI excluding periprocedural MI [1 year]

   Target vessel MI excluding periprocedural MI

7. Target vessel MI including periprocedural MI [1 year]

   Target vessel MI including periprocedural MI

8. Clinically indicated target lesion revascularization [1 year]

   Clinically indicated target lesion revascularization

9. Clinically indicated target vessel revascularization [1 year]

   Clinically indicated target vessel revascularization

10. Any revascularization [1 year]

    Any revascularization

11. 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

12. Cardiovascular death or target vessel MI [1 year]

    Cardiovascular death or target vessel MI

13. All-cause death or non-fatal MI [1 year]

    All-cause death or non-fatal MI

14. 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

15. 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

16. Cardiovascular death, target vessel MI, or vessel or stent thrombosis [1 year]

    Cardiovascular death, target vessel MI, or vessel or stent thrombosis

17. 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

18. Major bleeding events (BARC type 2, 3, or 5) [1 year]

    Major bleeding events (BARC type 2, 3, or 5)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bon-Kwon Koo	Seoul		Korea, Republic of

Sponsors and Collaborators

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

Investigators

• Study Chair: Bon-Kwon Koo, MD, PhD, [phone]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bon-Kwon Koo, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT06104033
• Other Study ID Numbers: 2306-138-1440
• First Posted: Oct 27, 2023
• Last Update Posted: Oct 27, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bon-Kwon Koo, Professor, Seoul National University Hospital: Coronary artery disease; Multivessel coronary artery disease; Percutaneous coronary intervention; Drug-coated balloon; Drug-eluting stent
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Study Results

No Results Posted as of Oct 27, 2023