Evaluating the effectiveness of drug-eluting balloons for coronary artery disease
Evaluation of Effectiveness and Safety of Drug-Eluting Balloon in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study
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 |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 9 sites (Bucheon-si and 8 other locations) |
| Trial ID | NCT02038660 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 and older who have undergone balloon angioplasty for coronary artery disease.
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.
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 performed: Other studies have shown promising results with drug-eluting balloons in similar contexts, indicating a potential for success in this observational study.
Eligibility criteria
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 this trial is running
Bucheon-si and 8 other locations
- Soon Chun Hyang University Hospital Bucheon — Bucheon-si, South Korea (Terminated)
- Keimyung University Dongsan Medical Center — Daegu, South Korea (Recruiting)
- The Catholic University of Korea, Daejeon ST. Mary's Hospital — Daejeon, South Korea (Terminated)
- 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)
- Korea University Guro Hospital — Seoul, South Korea (Not_yet_recruiting)
- Ulsan University Hospital — Ulsan, South Korea (Recruiting)
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.