Unique ID issued by UMIN | UMIN000000755 |
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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 |
Multi-center prospective randomized control trial of Biolimus Eluting Stent System(TRE-956)
TRE-956 clinical trial
Multi-center prospective randomized control trial of Biolimus Eluting Stent System(TRE-956)
TRE-956 clinical trial
Japan |
ischemic heart disease
Medicine in general | Cardiology |
Others
NO
to confirm efficacy and safty of TRE-956
Safety,Efficacy
Confirmatory
Phase III
TVF at 9M
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
YES
Central registration
2
Treatment
Device,equipment |
Implantation of TRE-956
Implantation of Cypher
20 | years-old | <= |
Not applicable |
Male and Female
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).
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%).
335
1st name | |
Middle name | |
Last name | Kazuaki Mitsudo,MD , Hidehiko Honda.MD |
Kurashiki central hospital
Sendai kousei hospital
Cardiology ,Cardiology
1-1-1 Miwa,Kurashiki City,Okayama Prefecture ,Japan ,4-15 Hirose-cho,Aoba district,Sendai City,Miyagi Prefecture,Japan
1st name | |
Middle name | |
Last name |
Terumo corporation
Clinical development department
Terumo corporation
Terumo corporation
Profit organization
NO
2007 | Year | 07 | Month | 02 | Day |
Published
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.
Completed
2007 | Year | 05 | Month | 15 | Day |
2007 | Year | 07 | Month | 01 | Day |
2009 | Year | 07 | Month | 01 | Day |
2007 | Year | 06 | Month | 28 | Day |
2010 | Year | 05 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000907
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