Registry comparing different drug-eluting stents for coronary artery disease
Prospective Registry for Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention in Gangwon Province
This study is testing how well different types of drug-eluting stents work for people with coronary artery disease who are getting heart procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 3 sites (Chuncheon, Gangwon-do and 2 other locations) |
| Trial ID | NCT02038127 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to compare the effectiveness of various drug-eluting stents, including Biolimus-eluting, Everolimus-eluting, and Zotarolimus-eluting stents, in patients with coronary artery disease who are undergoing percutaneous coronary intervention. Participants must be over 19 years old and have significant coronary artery stenosis along with evidence of myocardial ischemia. The study will gather data on patient outcomes to evaluate the performance of these stents in a real-world clinical setting.
Who should consider this trial
Good fit: Ideal candidates include adults over 19 years with significant coronary artery stenosis and evidence of myocardial ischemia.
Not a fit: Patients with known hypersensitivity to the medications or materials used in the stents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with coronary artery disease, enhancing stent selection and patient outcomes.
How similar studies have performed: Other studies have shown success in comparing drug-eluting stents, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 19 years * Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the drug-eluting stent(s) and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure * Subject must have significant stenosis (\>50% by visual estimate) on a native or in-stent coronary artery * Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, acute myocardial infarction, positive functional study or a reversible changes in the ECG consistent with ischemia). In subjects with coronary artery stenosis \>75%, evidence of myocardial ischemia does not have to be documented Exclusion Criteria: * Subject has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, biolimus A9, everolimus, zotarolimus, stainless steel, cobalt chromium, contrast media (Patients with documented sensitivity to contrast media, which can be effectively premedicated with steroid and diphenhydramine may be enrolled. However, those with true anaphylaxis to prior contrast media should not be enrolled.) * Subject in use of systemic (intravenous) biolimus A9, everolimus or zotarolimus within 12 months. * Female subject of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study * Subject planned an elective surgical procedure that would necessitate interruption of antiplatelet during the first 12 months post enrollment * Subject with non-cardiac co-morbid condition with life expectancy \< 2 year or that may result in protocol non-compliance (per site investigator's medical judgment) * Subject with cardiogenic shock at presentation * Subject who are actively participating in another drug or device investigational study, who have not completed the primary end point follow-up period
Where this trial is running
Chuncheon, Gangwon-do and 2 other locations
- Chuncheon Hallym University Hospital — Chuncheon, Gangwon-do, South Korea (Not_yet_recruiting)
- Yonsei University Wonju Christian Hospital — Wŏnju, Gangwon-do, South Korea (Recruiting)
- Korea University Guro Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Junghan Yoon, M.D., Ph.D. — Yonsei University
- Study coordinator: Junghan Yoon, M.D., Ph.D.
- Email: jyoon@yonsei.ac.kr
- Phone: +82-33-741-0906
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.