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NCT Number: NCT06104033

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Multi Vessel Coronary Artery Disease Myocardial Ischemia Vascular Diseases

Age range

19 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 19 or older
  • 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
  • Capable of understanding the risks and benefits of participating in the study and providing informed consent

Exclusion criteria

  • Incapable of voluntarily providing informed consent
  • Allergy or contraindication to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
  • Cardiogenic shock or cardiac arrest patients
  • Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
  • Patients for whom coronary artery bypass surgery is prioritized over coronary artery intervention
  • Patients with severe valvular heart disease requiring open heart surgery
  • Pregnant or lactating women

Treatment and study plan

Drug-coated Balloon

Device

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

Device

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.

Primary outcomes

  1. The reclassification rate of the treatment strategy

    Time frame: 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 outcomes

  1. Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy

    Time frame: 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

    Time frame: 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

    Time frame: 1 year

    Cardiovascular death

  4. All-cause death

    Time frame: 1 year

    All-cause death

  5. Non-fatal myocardial infarction (MI)

    Time frame: 1 year

    Non-fatal myocardial infarction (MI)

  6. Target vessel MI excluding periprocedural MI

    Time frame: 1 year

    Target vessel MI excluding periprocedural MI

  7. Target vessel MI including periprocedural MI

    Time frame: 1 year

    Target vessel MI including periprocedural MI

  8. Clinically indicated target lesion revascularization

    Time frame: 1 year

    Clinically indicated target lesion revascularization

  9. Clinically indicated target vessel revascularization

    Time frame: 1 year

    Clinically indicated target vessel revascularization

  10. Any revascularization

    Time frame: 1 year

    Any revascularization

  11. Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition

    Time frame: 1 year

    Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition

  12. Cardiovascular death or target vessel MI

    Time frame: 1 year

    Cardiovascular death or target vessel MI

  13. All-cause death or non-fatal MI

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 1 year

    All-cause death, non-fatal MI, or clinically indicated target vessel revascularization

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

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Bon-Kwon Koo, MD, PhD

CONTACT

[email protected]

+82-2-2072-2062

Sponsors and collaborators

Lead sponsor

Bon-Kwon Koo

Other

Collaborators

  • Ajou University School of Medicine
  • Chonnam National University Hospital
  • Chosun University Hospital
  • Chung-Ang University Gwangmyeong Hospital
  • Chung-Ang University Hospital
  • 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
  • Sejong General 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 University Hospital
  • Uijeongbu St. Mary Hospital
  • Ulsan Medical Center
  • Ulsan University Hospital
  • Wonju Severance Christian Hospital
  • Yeungnam University Hospital

Registry information

Acronym: DCB-MVD

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 27, 2023
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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