Coronary Artery Disease
Conditions
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
Interventions
None listed
Sponsors
Yonsei University
Gangwon Cardiovascular Health Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device-oriented composite outcome | 24 months | Device-oriented composite consisted of cardiac death, MI not clearly attributable to a nontarget vessel, and clinically indicated TLR at 24-month clinical follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-oriented composite outcome | 24 months | Patient-oriented composite consisted of all-cause mortality, any MI, and any revascularization at 24-month clinical follow-up |
| Target vessel revascularization | 12 months | — |
| ARC defined stent thrombosis | 12 months | — |
Countries
South Korea
Contacts
CONTACTJunghan Yoon, M.D., Ph.D.
CONTACTYoung Jin Youn, M.D.
PRINCIPAL_INVESTIGATORJunghan Yoon, M.D., Ph.D.
Yonsei University
Outcome results
None listed