| NCT ID | NCT02038127 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2013-01-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2013-01-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Comparison of * Biolimus-eluting stent, Biomatrix, or Biomatrix Flex stent, Biosensors, Singapore * Everolimus-eluting stent, Xience V, or Xience Prime, or Xience Xpedition stent, Abbott, USA * Zotarolimus-eluting stent, Endeavor Resolute, or Endeavor Resolute Integrity stent Medtronic, USA in patients with coronary artery disease treated with percutaneous coronary intervention
Eligibility 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
Contact & Investigator
Junghan Yoon, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Yonsei University
Frequently Asked Questions
Who can join the NCT02038127 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02038127 currently recruiting?
Yes, NCT02038127 is actively recruiting participants. Contact the research team at jyoon@yonsei.ac.kr for enrollment information.
Where is the NCT02038127 trial being conducted?
This trial is being conducted at Chuncheon, South Korea, Wŏnju, South Korea, Seoul, South Korea.
Who is sponsoring the NCT02038127 clinical trial?
NCT02038127 is sponsored by Yonsei University. The principal investigator is Junghan Yoon, M.D., Ph.D. at Yonsei University. The trial plans to enroll 5,000 participants.