Coronary StenosisBEGINNCT01574586
Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience
A study testing Bifurcation stenting in people with Coronary Stenosis, run by Kurashiki Central Hospital at 1 site in Japan.
Trial summary
The primary objective of this study is to make a comparison of safety and efficacy of DESs with different link number (2-link Nobori and 3-link Xience) in patients with de novo true bifurcation lesions. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Stenosis
- What is being tested?
- Bifurcation stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2012to Jun 2015
- Phase
- Interventional
- 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
- Patient eligible for percutaneous coronary intervention
- Patient or substitute decision-maker willing to provide written informed consent, which is approved by the Institutional Review Board or its equivalence
- De novo stenosis at coronary bifurcation with up to two vessels (visually estimated diameter stenosis ≥50%)
- Second vessel at coronary bifurcation treatable with trial device during the procedure
- True coronary bifurcation, ≥50% diameter stenosis in both the main and side branches, belonging to the Medina classes 1.1.1, 1.0.1, and 0.1.1,
- Visually estimated target lesion reference vessel diameter, 2.5-5.0 mm in the main branch, ≥2.25 mm in the side branch
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- Target lesion treatable with one or two stents in both the main and side branches
- Consensus of PCI after discussion between cardiologists and cardiac surgeons for the lesion in the left main coronary artery
- Thrombolysis in Myocardial Infarction grade ≥1 flow in both the main and side branches
Who cannot join
- General restrictions
- Unable to be followed by the implementing medial institution
- Life expectancy <1 year
- Acute myocardial infarction (<1 week)
- Left ventricular ejection fraction <30%
- Scheduled for elective treatment requiring antiplatelet drug Withdrawal
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- Deemed as unsuitable by the investigator or subinvestigator
- Serum creatinine level ≥2.0 Mg/dl
- Vascular morphological restrictions
- Lesion proximal to coronary artery bypass graft anastomotic site (visual estimation ≤5.0 mm) or including a part of coronary artery bypass grafting
- In-stent restenosis
- Severe calcification
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized Trial to Compare 2 Link Nobori and 3 Link Xience Stents in Bifurcation Stenting
The primary objective of this study is to make a comparison of safety and efficacy of DESs with different link number (2-link Nobori and 3-link Xience) in patients with de novo true bifurcation lesions.
The minimum lumen diameter of the side branch ostium in bifurcation at 8 months and the MACE rate until one year after PCI will be assessed in both groups.
- Conditions
- Coronary Stenosis
- Being tested
- Bifurcation stenting
- Keywords
- True Bifurcation stenosis
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifurcation stentingDevice
Bifurcation stenting using 2-link stent Nobori versus 3-link stent Xience
| Study group | Role | What they receive |
|---|---|---|
| 2-link stent Nobori | Active comparator | Bifurcation stenting Receives: Device: Bifurcation stenting |
| 3-link stent Xience | Active comparator | Bifurcation stenting Receives: Device: Bifurcation stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum lumen diameter of the side branch ostium in bifurcation
Measured: 8 months
Secondary outcomes (1)
Incidence of MACE
Measured: in-hospital, 30 days, 8 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2014
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kurashiki Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574586
- Sponsor's protocol ID
- BEGIN12
- Acronym
- BEGIN
- Status last verified
- Apr 2015
- First submitted
- 6 Apr 2012
- Last updated
- 7 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Trial to Compare 2 Link Nobori and 3 Link Xience Stents in Bifurcation Stenting
- ClinicalTrials.gov ID
- NCT01574586
- Acronym / sponsor ID
- BEGIN / BEGIN12
- Conditions
- Coronary Stenosis
- Keywords
- True Bifurcation stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Kurashiki Central HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2015 (estimated)
- First posted
- 10 Apr 2012 (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.
The primary objective of this study is to make a comparison of safety and efficacy of DESs with different link number (2-link Nobori and 3-link Xience) in patients with de novo true bifurcation lesions.
The minimum lumen diameter of the side branch ostium in bifurcation at 8 months and the MACE rate until one year after PCI will be assessed in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-link stent Nobori | Active comparator | Device: Bifurcation stentingBifurcation stenting |
| 3-link stent Xience | Active comparator | Device: Bifurcation stentingBifurcation stenting |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient eligible for percutaneous coronary intervention
- Patient or substitute decision-maker willing to provide written informed consent, which is approved by the Institutional Review Board or its equivalence
- De novo stenosis at coronary bifurcation with up to two vessels (visually estimated diameter stenosis ≥50%)
- Second vessel at coronary bifurcation treatable with trial device during the procedure
- True coronary bifurcation, ≥50% diameter stenosis in both the main and side branches, belonging to the Medina classes 1.1.1, 1.0.1, and 0.1.1,
Key exclusion criteria (12 listed)
- General restrictions
- Unable to be followed by the implementing medial institution
- Life expectancy <1 year
- Acute myocardial infarction (<1 week)
- Left ventricular ejection fraction <30%
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 |
|---|---|---|
| Bifurcation stentingBifurcation stenting using 2-link stent Nobori versus 3-link stent Xience | Device | 2-link stent Nobori, 3-link stent Xience |
Primary outcome
Minimum lumen diameter of the side branch ostium in bifurcation
Time frame: 8 months
1 secondary outcome
Incidence of MACE
Time frame: in-hospital, 30 days, 8 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifurcation stenting in people with Coronary Stenosis, run by Kurashiki Central Hospital at 1 site in Japan.
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 9 inclusion and 12 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 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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.
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?
Minimum lumen diameter of the side branch ostium in bifurcation (time frame: 8 months). 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 7 Apr 2015; AzTrials last refreshed its copy on 30 Oct 2026.