Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents
BESS
1 other identifier
interventional
1,462
1 country
26
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®)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Dec 2010
Longer than P75 for phase_4 coronary-artery-disease
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 29, 2010
CompletedFirst Posted
Study publicly available on registry
December 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedFebruary 12, 2014
February 1, 2014
4.6 years
December 29, 2010
February 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
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
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
- +6 more secondary outcomes
Study Arms (2)
Promus Element
ACTIVE COMPARATOREverolimus-eluting stent
Nobori
ACTIVE COMPARATORBiolimus-eluting stent with biodegradable polymer
Interventions
Everolimus-eluting stent
Biolimus-eluting stent with biodegradable polymer
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Hallym University Sacred Heart Hospital
Anyang, South Korea
Sejong Hospital
Bucheon-si, South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
Soon Chun Hyang University Hospital Cheonan
Cheonan, South Korea
Kangwon National University Hospital
Chuncheon, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Konyang University Hospital
Daejeon, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Inje University ilsan Paik Hospital
Ilsan, South Korea
Gachon University Gil Hospital
Incheon, South Korea
Cheju Halla General Hospital
Jeju City, South Korea
Pusan National University Hospital
Pusan, South Korea
Hallym University Hankang Sacred Heart Hospital
Seoul, South Korea
Hallym University Kangdong Sacred Heart Hospital
Seoul, South Korea
Kyunghee University Medical Center
Seoul, South Korea
The Catholic University of Korea Seoul ST. Mary's Hospital
Seoul, South Korea
Yonsei University Gangnam Severance Hospital
Seoul, South Korea
St. Carollo Hospital
Suncheon, South Korea
Ajou University Medical Center
Suwon, South Korea
Catholic University ST. Vincent's Hospital
Suwon, South Korea
Ulsan University Hospital
Ulsan, South Korea
Yonsei University Wonju College of Medicine Wonju Christion Hospital
Wŏnju, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Jea Tahk, MD, PhD
Department of Cardiology, Ajou University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
December 29, 2010
First Posted
December 30, 2010
Study Start
December 1, 2010
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
February 12, 2014
Record last verified: 2014-02