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Recruiting NCT06104033

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

— Observational Coronary Artery Disease Multi Vessel Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: drug-coated balloon, drug-eluting stent.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Multi Vessel Coronary Artery Disease. Basic parameters: 19 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • The reclassification rate of the treatment strategy [Time frame: At the time of procedure]
Secondary outcome measures (12)
  • 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 lesion therapy [Time frame: At the time of procedure]
  • Cardiovascular death [Time frame: 1 year]
  • All-cause death [Time frame: 1 year]
  • Non-fatal myocardial infarction (MI) [Time frame: 1 year]
  • Target vessel MI excluding periprocedural MI [Time frame: 1 year]
  • Target vessel MI including periprocedural MI [Time frame: 1 year]
  • Clinically indicated target lesion revascularization [Time frame: 1 year]
  • Clinically indicated target vessel revascularization [Time frame: 1 year]
  • Any revascularization [Time frame: 1 year]
  • Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition [Time frame: 1 year]
  • Cardiovascular death or target vessel MI [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Bon-Kwon Koo — Seoul

Identifiers

NCT: NCT06104033 · 2306-138-1440

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗