Clinical trial NCT01268371: Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents
Official title: Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Stent
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2010-12-30
Enrollment: 1462
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®)


Eligibility criteria: 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

Primary outcomes:
measure: The Number of Participants with Majour Adverse Cardiac Events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis
timeFrame: 1 year after index procedure
Secondary outcomes:
measure: The number of participants with majour adverse cardiac events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis
timeFrame: 2 years after index procedure
measure: Death (all-cause and cardiac)
timeFrame: 1 to 2 years after index procedure
measure: Myocardial infarction (Q wave and non-Q wave)
timeFrame: 1 to 2 years after index procedure
measure: Target vessel revascularization (ischemia- and clinically-driven)
timeFrame: 1 to 2 years after index procedure
measure: Target lesion revascularization (ischemia- and clinically-driven)
timeFrame: 1 to 2 years after index procedure
measure: Stent thrombosis
timeFrame: 1 to 2 years after index procedure
measure: In-stent and in-segment late loss at 1 year angiographic follow-up
timeFrame: 1 year after index procedure
measure: In-stent and in-segment restenosis at 1 year angiographic follow-up
timeFrame: 1 year after index procedure
measure: Incidence and angiographic pattern of restenosis at 1 year angiographic follow-up
timeFrame: 1 year after index procedure
measure: The incidence of Procedural success
timeFrame: index procedure (day 0)
measure: The number of participants with death and myocardial infarction
timeFrame: 1 to 2 years after index procedure
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon
country: Korea, Republic of
facility: Sejong Hospital
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Cheju
country: Korea, Republic of
facility: Cheju Halla General Hospital
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daejon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejon
country: Korea, Republic of
facility: Konyang University Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University ilsan Paik Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Hankang Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Gangnam Severance Hospital
city: Suncheon
country: Korea, Republic of
facility: St. Carollo Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Medical Center
city: Suwon
country: Korea, Republic of
facility: Catholic University ST. Vincent's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju College of Medicine Wonju Christion Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Department of Cardiology, Ajou University School of Medicine
name: Seung-Jea Tahk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: