Coronary Artery Disease
Conditions
Keywords
Coronary artery disease, Stent
Brief summary
To compare the safety and efficacy of coronary stenting with everolimus-eluting stent (Promus Element®) and biolimus-eluting stent with biodegradable polymer (Nobori®)
Interventions
DEVICEPromus Element, Boston Scientific Corporation
Everolimus-eluting stent
DEVICENobori, Terumo Corporation (Japan)
Biolimus-eluting stent with biodegradable polymer
Sponsors
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Significant coronary artery stenosis (\> 50% by visual estimate) * Stable angina, unstable angina, Non-ST elevation myocardial infarction (NSTEMI) and documented silent ischemia * Patients eligible for intracoronary stenting * age ≥ 20 years old
Exclusion criteria
* ST segment elevation myocardial infarction (within 24 hours) * Low ejection fraction (\< 25%) * Cardiogenic shock * History of bleeding diathesis or known coagulopathy * Limited life-expectancy (less than 1 year) due to combined serious disease * Contraindication to heparin, sirolimus, everolimus and biolimus * Contraindication to aspirin and clopidogrel * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Number of Participants with Majour Adverse Cardiac Events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis | 1 year after index procedure |
Secondary
| Measure | Time frame |
|---|---|
| Death (all-cause and cardiac) | 1 to 2 years after index procedure |
| Myocardial infarction (Q wave and non-Q wave) | 1 to 2 years after index procedure |
| Target vessel revascularization (ischemia- and clinically-driven) | 1 to 2 years after index procedure |
| Target lesion revascularization (ischemia- and clinically-driven) | 1 to 2 years after index procedure |
| Stent thrombosis | 1 to 2 years after index procedure |
| The number of participants with majour adverse cardiac events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis | 2 years after index procedure |
| In-stent and in-segment restenosis at 1 year angiographic follow-up | 1 year after index procedure |
| Incidence and angiographic pattern of restenosis at 1 year angiographic follow-up | 1 year after index procedure |
| The incidence of Procedural success | index procedure (day 0) |
| The number of participants with death and myocardial infarction | 1 to 2 years after index procedure |
| In-stent and in-segment late loss at 1 year angiographic follow-up | 1 year after index procedure |
Countries
South Korea
Outcome results
None listed