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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000755
Receipt No. R000000907
Scientific Title Multi-center prospective randomized control trial of Biolimus Eluting Stent System(TRE-956)
Date of disclosure of the study information 2007/07/02
Last modified on 2010/05/06

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Basic information
Public title Multi-center prospective randomized control trial of Biolimus Eluting Stent System(TRE-956)
Acronym TRE-956 clinical trial
Scientific Title Multi-center prospective randomized control trial of Biolimus Eluting Stent System(TRE-956)
Scientific Title:Acronym TRE-956 clinical trial
Region
Japan

Condition
Condition ischemic heart disease
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to confirm efficacy and safty of TRE-956
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes TVF at 9M
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Implantation of TRE-956
Interventions/Control_2 Implantation of Cypher
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 Patient is eligible for PCI or CABG.
The target lesion is a single de novo coronary artery lesion one or 2 vessels.
The target lesion length must be <= 30 mm (visual estimate).
The target reference vessel diameter must be >= 2.5mm and <= 3.5mm (visual estimate).
Key exclusion criteria Evidence of an acute myocardial infarction within 72 hours of the intended treatment.
Stroke or transient ischemic attack within the prior 90 days.
Active peptic ulcer or upper GI bleeding within the prior 180days.
Documented LVEF <30%.
Patient has received a immunosuppressant.
Planned surgery with antiplatelet drug withdrawal after index procedure.
Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment.
Previous DES ( less than 1 year) anywhere within the target vessel .
Significant (>50%) stenosis proximal or distal to the target lesion .
Ostial or bifurcation target lesion
Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated.
Target lesion is located or supplied by an arterial or venous bypass graft.
Target lesion involves a side branch >2.0mm in diameter.
The target lesion requires treatment with a device other than PTCA prior to stent placement .
Unprotected Left main coronary artery disease (stenosis >50%).
Target sample size 335

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuaki Mitsudo,MD , Hidehiko Honda.MD
Organization Kurashiki central hospital
Sendai kousei hospital
Division name Cardiology ,Cardiology
Zip code
Address 1-1-1 Miwa,Kurashiki City,Okayama Prefecture ,Japan ,4-15 Hirose-cho,Aoba district,Sendai City,Miyagi Prefecture,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Terumo corporation
Division name Clinical development department
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Terumo corporation
Institute
Department

Funding Source
Organization Terumo corporation
Organization
Division
Category of Funding Organization Profit organization
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 07 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results 2010 ACC
Results
As for the primary end point, TVF rate of Nobori group was non-inferior compared to SES group at 9 months (7.4% versus 6.3%; non-inferiority test (P<0.001)) As for secondary end point at 8months, LL of Nobori group showed 0.12 +/- 0.30 mm versus SES group 0.14+/- 0.34 mm (95%CI, -0.09 to 0.05). %DS of Nobori group showed 12.1% +/- 9.3% versus SES group 15.3% +/- 13.7% (95%CI, -5.6 to 0.8). RR of Nobori group showed 2.4% versus SES group 3.6% (95%CI, -5.0~2.5). MACE was 5.3% in Nobori group and 6.3% in SES group (95%CI, -6.2 to 4.3). No stent thrombosis defined as definite or probable in ARC definition was occurred up to 9 months in both groups.

Conclusions
The primary end point, TVF showed this first Japanese Good Clinical Practice regulated RCT confirmed Nobori group is non inferior compare to SES group (Cypher). Long term clinical follow-up is undergoing and expect to be investigated.
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 Completed
Date of protocol fixation
2007 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
2009 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 06 Month 28 Day
Last modified on
2010 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000907

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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