Reducing plaque in coronary arteries using a drug-coated balloon
Drug-Coated Balloon Angioplasty Facilitates Rapid Reduction in Plaque Lipid Burden in Patients with Multivessel Coronary Artery Disease: a Serial NIRS-IVUS Imaging Study
Korea University Ansan Hospital · NCT05438121
This study is testing if a special drug-coated balloon can help reduce plaque in the arteries of people with serious heart disease better than regular medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 65 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Korea University Ansan Hospital (other) |
| Locations | 1 site (Ansan-si, Gyeonggi-do) |
| Trial ID | NCT05438121 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with significant multivessel coronary artery disease requiring revascularization and suitable de novo lesions for DCB angioplasty.
Not a fit: Patients who are hemodynamically unstable, have severe comorbidities, or unsuitable lesions for DCB angioplasty may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved stabilization of coronary plaques and reduced risk of heart attacks for patients with coronary artery disease.
How similar studies have performed: While statin therapy has shown benefits in plaque stabilization, the use of DCB for this purpose is a novel approach that has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ansan-si, Gyeonggi-do
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, Atherosclerotic Plaque, De Novo Stenosis, drug coated balloon, Near infrared spectroscopy, NIRS-IVUS, De novo coronary lesion