Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Promus Element, Boston Scientific CorporationDevice: Nobori, Terumo Corporation (Japan)
- Registration Number
- NCT01268371
- Lead Sponsor
- Ajou University School of Medicine
- 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®)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1462
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Promus Element Promus Element, Boston Scientific Corporation Everolimus-eluting stent Nobori Nobori, Terumo Corporation (Japan) Biolimus-eluting stent with biodegradable polymer
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 Death (all-cause and cardiac) 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 In-stent and in-segment late loss at 1 year angiographic follow-up 1 year 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
Trial Locations
- Locations (26)
St. Carollo Hospital
🇰🇷Suncheon, Korea, Republic of
Yonsei University Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Inje University ilsan Paik Hospital
🇰🇷Ilsan, Korea, Republic of
Hallym University Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul ST. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Hallym University Hankang Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejon, Korea, Republic of
Sejong Hospital
🇰🇷Bucheon, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, Korea, Republic of
Cheju Halla General Hospital
🇰🇷Cheju, Korea, Republic of
Catholic University ST. Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Incheon, Korea, Republic of
Kangwon National University Hospital
🇰🇷Chuncheon, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Konyang University Hospital
🇰🇷Daejon, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Kyunghee University Medical Center
🇰🇷Seoul, Korea, Republic of
Ajou University Medical Center
🇰🇷Suwon, Korea, Republic of
Yonsei University Wonju College of Medicine Wonju Christion Hospital
🇰🇷Wonju, Korea, Republic of