Evaluating the effectiveness of drug-eluting balloons for coronary artery disease
Official title: Evaluation of Effectiveness and Safety of Drug-Eluting Balloon in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study
Run by Asan Medical Center · NCT02038660 · Data updated 2026-11-12
This study is testing how well drug-eluting balloons work for treating coronary artery disease in real-life settings and keeping patients safe after their balloon angioplasty.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 9 sites (Bucheon-si and 8 other locations) |
| Status | Recruiting |
| Started | January 2014 |
| Main results expected | December 31, 2026 |
| Study ends | June 2027 |
| Registry record updated | December 29, 2025 |
| Trial ID | NCT02038660 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 20 and older who have undergone balloon angioplasty for coronary artery disease.
✕Probably not a fit
Patients with allergies to paclitaxel or antiplatelet medications, or those with a history of bleeding disorders, may not benefit from this study.
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 aims to assess the long-term effectiveness and safety of drug-eluting balloons used in balloon angioplasty for patients with coronary artery disease in real-world clinical settings. Participants will be monitored after receiving treatment to gather data on outcomes and any potential complications. The study includes patients aged 20 and older who have undergone balloon angioplasty and meet specific inclusion criteria, while those with certain allergies or bleeding disorders will be excluded.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term benefits and safety of drug-eluting balloons, potentially improving treatment strategies for coronary artery disease.
How similar studies have gone: Other studies have shown promising results with drug-eluting balloons in similar contexts, indicating a potential for success in this observational study.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * After pre dilatation residual stenosis 30% and less and also without vessel dissection interrupted blood flow * Age 20 and more * Treated with Balloon angioplasty * Signed informed consent and agreed to follow protocol Exclusion Criteria: * Allergy to paclitaxel, antiplatelet * History of side effect to heparin, aspirin, thienopyridines * History of bleeding tendency, coagulation disorder, blood transfusion reaction
Where it's running
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Keimyung University Dongsan Medical Center
Daegu, South Korea Recruiting -
Chonnam National University Hospital
Gwangju, South Korea Recruiting -
Dong-A Medical Center
Pusan, South Korea Recruiting -
Asan Medical Center
Seoul, South Korea Recruiting -
Gangnam Severance Hospital
Seoul, South Korea Recruiting -
Ulsan University Hospital
Ulsan, South Korea Recruiting
Show 3 more locations
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Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea Terminated -
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, South Korea Terminated -
Korea University Guro Hospital
Seoul, South Korea Not yet recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.