UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000755
Receipt number 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 11:24:09

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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 or person

Institute

Terumo corporation

Institute

Department

Personal name



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

Value
https://center6.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