Reducing plaque in coronary arteries using a drug-coated balloon

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the effectiveness of drug-coated balloon (DCB) angioplasty in reducing lipid burden in coronary atherosclerotic plaques compared to traditional statin-based medical treatment. The study will assess changes in plaque composition using near infrared spectroscopy (NIRS) at 6-9 months after the procedure. Patients with significant multivessel coronary artery disease and suitable de novo lesions will be included, while those with certain exclusions will not be eligible. The goal is to determine if DCB can provide a more immediate benefit in stabilizing coronary plaques.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with significant multivessel coronary artery disease requiring revascularization
* Any De novo lesions (reference vessel diameter of 2.25mm\~4.0mm) suitable for DCB angioplasty
* Lesion suitable for intravascular imagings
* Written informed consent

Exclusion Criteria:

* Hemodynamically unstable or cardiogenic shock
* Left main stenotic lesion or graft vessel lesion
* Visible angiographic thrombus, not resolved by balloon angioplasty
* Pregnancy or breastfeeding
* Comorbidities with life expectancy \< 12 months
* Severe coronary calcification or tortuosity, hindering timely DCB delivery

Where it's running

• Korea University Ansan Hospital
  Ansan-si, Gyeonggi-do, South Korea Recruiting

Study contacts

• Principal investigator: Sunwon Kim, MD, PhD — Korea University Ansan Hospital
• Study coordinator: Sunwon Kim, MD, PhD
• Email: sunwon11@hanmail.net
• Phone: 82-31-8099-6349

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.