Using drug-coated balloons for treating multi-vessel coronary artery disease
Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease
This study tests whether using drug-coated balloons can help people with multi-vessel coronary artery disease feel better compared to the usual treatment with drug-eluting stents.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 19 Years to 100 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06104033 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of drug-coated balloons (DCBs) in treating coronary artery lesions in patients with multi-vessel coronary artery disease, comparing it to the standard use of drug-eluting stents (DES). It is a prospective, multicenter, open-label study that aims to assess how the introduction of DCBs may change clinical practice and improve patient outcomes. The study will evaluate clinical outcomes and the impact of a hybrid treatment strategy that incorporates both DCBs and DES.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 or older with multi-vessel coronary artery disease requiring coronary intervention.
Not a fit: Patients who are unable to provide informed consent or have severe cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with multi-vessel coronary artery disease.
How similar studies have performed: Other studies have shown promise in using drug-coated balloons for coronary interventions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 19 or older 2. 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 3. Capable of understanding the risks and benefits of participating in the study and providing informed consent Exclusion Criteria: 1. Incapable of voluntarily providing informed consent 2. Allergy or contraindication to aspirin, P2Y12 inhibitors, or components of drug-eluting stents 3. Cardiogenic shock or cardiac arrest patients 4. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%) 5. Patients for whom coronary artery bypass surgery is prioritized over coronary artery intervention 6. Patients with severe valvular heart disease requiring open heart surgery 7. Pregnant or lactating women
Where this trial is running
Seoul
- Bon-Kwon Koo — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Bon-Kwon Koo, MD, PhD
- Email: bkkoo@snu.ac.kr
- Phone: +82-2-2072-2062
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.