Actively Recruiting

Age: 19Years - 100Years
All Genders
NCT06104033

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

Led by Bon-Kwon Koo · Updated on 2023-10-27

500

Participants Needed

1

Research Sites

162 weeks

Total Duration

On this page

Sponsors

B

Bon-Kwon Koo

Lead Sponsor

S

Seoul National University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 19 or older
  • Diagnosis of multivessel coronary artery disease requiring coronary intervention
  • Stenosis in 2 or more major coronary arteries or branches with vessel size 2.5mm and diameter stenosis 50% or fractional flow reserve 0.80 requiring repeat revascularization
  • Stenotic lesions requiring revascularization with vessel size between 2.5mm and 3.0mm
  • Ability to understand risks and benefits of study participation and provide informed consent
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Bon-Kwon Koo

Seoul, South Korea

Actively Recruiting

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Research Team

B

Bon-Kwon Koo, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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