Coronary Artery Disease
Conditions
Keywords
coronary disease, stent
Brief summary
This randomized study is a multi-center, randomized, study to compare the efficacy of biolimus A9-eluting stent (Nobori) vs. everolimus-eluting stent (Promus Element) for long coronary lesions.
Detailed description
Following angiography, patients with significant diameter stenosis \>50% and lesion length(\> 25mm) requiring single or multiple long-stent placement(total stent length 28mm) by visual estimation and eligible for LONG-DES V trial inclusion and exclusion criteria will be randomized 1:1 to a) NOBORI and b) PROMUS-ELEMENT stent by the stratified randomization method.
Interventions
DEVICEBiolimus A9-eluting stent
drug-eluting stent
DEVICEEverolimus-eluting stent
drug-eluting stent
Sponsors
CardioVascular Research Foundation, Korea
Seung-Jung Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must be at least 18 years of age. * Significant native coronary artery stenosis (\>50% by visual estimate) with lesion length of more than 25mm, which requiring single or multiple long stent placement (\>=28mm) * Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction * The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion criteria
* Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus. * An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment. * Acute ST-segment-elevation MI or cardiogenic shock * Terminal illness with life expectancy \<1 year * Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. * In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment, non-target vessel ISR is permitted) Patients with EF\<30%. * Serum creatinine level \>=3.0mg/dL or dependence on dialysis. * Patients with left main stem stenosis (\>50% by visual estimate).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-segment late luminal loss | 9 month angiographic follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Death (all-cause and cardiac) | 1 year |
| Myocardial infarction | 1 year |
| stent thrombosis(ARC criteria) | 1 year |
| target-lesion revascularization | 1 year |
| target-vessel revascularization | 1 year |
| Procedural success | at 1 day |
| Composite of death or MI | one month |
| Composite of cardiac death or MI | one month |
| In-stent late loss | 9 month angiographic follow-up |
| 8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) | 12 months |
| In-stent and in-segment restenosis | 9 month angiographic follow-up |
| Angiographic pattern of restenosis | 9 month angiographic follow-up |
Countries
South Korea
Outcome results
None listed