Coronary Artery DiseasePhase 4BESSNCT01268371
Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents
A Phase 4 study testing Promus Element, Boston Scientific Corporation and Nobori, Terumo Corporation (Japan) in people with Coronary Artery Disease, run by Ajou University School of Medicine at 26 sites in South Korea.
Trial summary
To compare the safety and efficacy of coronary stenting with everolimus-eluting stent (Promus Element®) and biolimus-eluting stent with biodegradable polymer (Nobori®) Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Promus Element, Boston Scientific Corporation and Nobori, Terumo Corporation (Japan)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,462 participants
- Where
- 26 sitesSouth Korea
- Study dates
- Dec 2010to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
South Korea26 sites
Hallym University Sacred Heart Hospital
Anyang
Sejong Hospital
Bucheon-si
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
Soon Chun Hyang University Hospital Cheonan
Cheonan
Kangwon National University Hospital
Chuncheon
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Hospital
Daegu
Chungnam National University Hospital
Daejeon
Konyang University Hospital
Daejeon
Gangneung Asan Hospital
Gangneung
Chonnam National University Hospital
Gwangju
Inje University ilsan Paik Hospital
Ilsan
Gachon University Gil Hospital
Incheon
Cheju Halla General Hospital
Jeju City
Pusan National University Hospital
Pusan
Hallym University Hankang Sacred Heart Hospital
Seoul
Hallym University Kangdong Sacred Heart Hospital
Seoul
Kyunghee University Medical Center
Seoul
The Catholic University of Korea Seoul ST. Mary's Hospital
Seoul
Yonsei University Gangnam Severance Hospital
Seoul
St. Carollo Hospital
Suncheon
Ajou University Medical Center
Suwon
Catholic University ST. Vincent's Hospital
Suwon
Ulsan University Hospital
Ulsan
Yonsei University Wonju College of Medicine Wonju Christion Hospital
Wŏnju
Pusan National University Yangsan Hospital
Yangsan
About this study
To compare the safety and efficacy of coronary stenting with everolimus-eluting stent (Promus Element®) and biolimus-eluting stent with biodegradable polymer (Nobori®)
- Conditions
- Coronary Artery Disease
- Being tested
- Promus Element, Boston Scientific Corporation, Nobori, Terumo Corporation (Japan)
- Keywords
- Coronary artery disease, Stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promus Element, Boston Scientific CorporationDevice
Also called Everolimus-eluting stent
Everolimus-eluting stent
Nobori, Terumo Corporation (Japan)Device
Also called Biolimus-eluting stent with biodegradable polymer
Biolimus-eluting stent with biodegradable polymer
| Study group | Role | What they receive |
|---|---|---|
| Promus Element | Active comparator | Everolimus-eluting stent Receives: Device: Promus Element, Boston Scientific Corporation |
| Nobori | Active comparator | Biolimus-eluting stent with biodegradable polymer Receives: Device: Nobori, Terumo Corporation (Japan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants with Majour Adverse Cardiac Events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis
Measured: 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
Measured: 2 years after index procedure
Death (all-cause and cardiac)
Measured: 1 to 2 years after index procedure
Myocardial infarction (Q wave and non-Q wave)
Measured: 1 to 2 years after index procedure
Target vessel revascularization (ischemia- and clinically-driven)
Measured: 1 to 2 years after index procedure
Target lesion revascularization (ischemia- and clinically-driven)
Measured: 1 to 2 years after index procedure
Stent thrombosis
Measured: 1 to 2 years after index procedure
In-stent and in-segment late loss at 1 year angiographic follow-up
Measured: 1 year after index procedure
In-stent and in-segment restenosis at 1 year angiographic follow-up
Measured: 1 year after index procedure
Incidence and angiographic pattern of restenosis at 1 year angiographic follow-up
Measured: 1 year after index procedure
The incidence of Procedural success
Measured: index procedure (day 0)
The number of participants with death and myocardial infarction
Measured: 1 to 2 years after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,462 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Jea Tahk, Ajou University School of Medicine
- Investigators
- Seung-Jea Tahk, MD, PhD, Principal investigator, Department of Cardiology, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268371
- Sponsor's protocol ID
- BESS
- Acronym
- BESS
- Status last verified
- Feb 2014
- First submitted
- 29 Dec 2010
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Biolimus-eluting Biodegradable Polymer, Everolimus-eluting and Sirolimus-eluting Coronary Stents
- ClinicalTrials.gov ID
- NCT01268371
- Acronym / sponsor ID
- BESS / BESS
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,462 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 30 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the safety and efficacy of coronary stenting with everolimus-eluting stent (Promus Element®) and biolimus-eluting stent with biodegradable polymer (Nobori®)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Promus Element | Active comparator | Device: Promus Element, Boston Scientific CorporationEverolimus-eluting stent |
| Nobori | Active comparator | Device: Nobori, Terumo Corporation (Japan)Biolimus-eluting stent with biodegradable polymer |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promus Element, Boston Scientific CorporationAlso: Everolimus-eluting stentEverolimus-eluting stent | Device | Promus Element |
| Nobori, Terumo Corporation (Japan)Also: Biolimus-eluting stent with biodegradable polymerBiolimus-eluting stent with biodegradable polymer | Device | Nobori |
Primary outcome
The Number of Participants with Majour Adverse Cardiac Events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis
Time frame: 1 year after index procedure
11 secondary outcomes
The number of participants with majour adverse cardiac events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis
Time frame: 2 years after index procedure
Death (all-cause and cardiac)
Time frame: 1 to 2 years after index procedure
Myocardial infarction (Q wave and non-Q wave)
Time frame: 1 to 2 years after index procedure
Target vessel revascularization (ischemia- and clinically-driven)
Time frame: 1 to 2 years after index procedure
Target lesion revascularization (ischemia- and clinically-driven)
Time frame: 1 to 2 years after index procedure
Stent thrombosis
Time frame: 1 to 2 years after index procedure
In-stent and in-segment late loss at 1 year angiographic follow-up
Time frame: 1 year after index procedure
In-stent and in-segment restenosis at 1 year angiographic follow-up
Time frame: 1 year after index procedure
Incidence and angiographic pattern of restenosis at 1 year angiographic follow-up
Time frame: 1 year after index procedure
The incidence of Procedural success
Time frame: index procedure (day 0)
The number of participants with death and myocardial infarction
Time frame: 1 to 2 years after index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Jea Tahk, MD, PhD principal investigator
Department of Cardiology, Ajou University School of Medicine
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Promus Element, Boston Scientific Corporation and Nobori, Terumo Corporation (Japan) in people with Coronary Artery Disease, run by Ajou University School of Medicine at 26 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants with Majour Adverse Cardiac Events (composite of death, myocardial infarction, target vessel revascularization and stent thrombosis (time frame: 1 year after index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2014.