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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007764
Receipt No. R000009101
Scientific Title A Multicenter, Randomized Trial to Compare 2 link Nobori and 3 link Xience Stents in Bifurcation Stenting
Date of disclosure of the study information 2012/04/16
Last modified on 2015/09/04

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Basic information
Public title A Multicenter, Randomized Trial to Compare 2 link Nobori and 3 link Xience Stents in Bifurcation Stenting
Acronym Bifurcation stenting using 2 link stent Nobori versus
3 link stent Xience (BEGIN)
Scientific Title A Multicenter, Randomized Trial to Compare 2 link Nobori and 3 link Xience Stents in Bifurcation Stenting
Scientific Title:Acronym Bifurcation stenting using 2 link stent Nobori versus
3 link stent Xience (BEGIN)
Region
Japan

Condition
Condition Coronary artery disease with de novo true bifurcation lesions
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To make a comparison of safety and efficacy of DESs with different link number (2-link Nobori and 3-link Xience/PROMUS) in patients with de novo true bifurcation lesions.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The minimum lumen diameter of the side branch ostium in bifurcation at 8 months after PCI.

Incidence of the Adverse events until one year after PCI.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 2-link biolimus-eluting stent (Nobori)
Interventions/Control_2 3-link everolimus-eluting stent(Xience)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patient eligible for percutaneous coronary intervention

2. Patient or substitute decision-maker willing to provide written informed consent, which is approved by the Institutional Review Board or its equivalence

3. De novo stenosis at coronary bifurcation with up to two vessels (visually estimated diameter stenosis >= 50%).
4. Second vessel at coronary bifurcation treatable with trial device during the procedure

5. 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

6. Visually estimated target lesion reference vessel diameter, 2.5-5.0 mm in the main branch, >=2.25 mm in the side branch

7. Target lesion treatable with one or two stents in both the main and side branches

8. Consensus of PCI after discussion between cardiologists and cardiac surgeons for the lesion in the left main coronary artery

9. Thrombolysis in Myocardial Infarction grade >=1 flow in both the main and side branches
Key exclusion criteria A. General restrictions
1. Unable to be followed by the implementing medical institution
2. Life expectancy <1 year
3. Acute myocardial infarction (<1 week)
4. Left ventricular ejection fraction < 30%
5. Scheduled for elective treatment requiring antiplatelet drug withdrawal
6. Deemed as unsuitable by the investigator or sub-investigator
7. Serum creatinine level >=2.0 mg/dl

B. Vascular morphological restrictions
1. Lesion proximal to coronary artery bypass graft anastomotic site (visual estimation <=5.0 mm) or including a part of coronary artery bypass grafting
2. In-stent restenosis
3. Severe calcification
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiya Muramatsu
Organization Saiseikai Yokohama City Eastern Hospital
Division name Divison of Cardiology
Zip code
Address 3-6-1 Shimosueyoshi Tsurumi-ward, Yokohama, Japan
TEL 045-576-3000
Email bigin-trial@kchnet.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name keiko Oka
Organization Kurashiki Central Hospital
Division name Clinical Research Center
Zip code
Address 1-1-1 Miwa, Kurashiki city, Okayama, Japan
TEL 086-422-0210
Homepage URL
Email kenkyu@kchnet.or.jp

Sponsor
Institute BEGIN trial investigators
Institute
Department

Funding Source
Organization Kurashiki Central Hospital
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT01574586
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 18 Day
Last follow-up date
2015 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 16 Day
Last modified on
2015 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009101

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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