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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002594
Receipt No. R000003168
Scientific Title Outcome in Hemodialysis of Taxus Liberte
Date of disclosure of the study information 2009/10/07
Last modified on 2014/10/07

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Basic information
Public title Outcome in Hemodialysis of Taxus Liberte
Acronym OUCH-TL
Scientific Title Outcome in Hemodialysis of Taxus Liberte
Scientific Title:Acronym OUCH-TL
Region
Japan

Condition
Condition Ischemic heart disease
Chronic renal failure on hemodialysis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the hemodialysis patient's outcome undergoing coronaru intervention using TAXUS Liberte stent
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Target Vessel Failure at 12 months
Key secondary outcomes Binary restenosis rate by QCA
Late lumen loss by QCA
Death, TLR, MACE at 12 months
Stent thrombosis rate
Neointimal volume by IVUS
Alpha 2 Macroglobulin and MACE rate
Dialyzer and MACE rate or late lumen loss

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 PCI with TAXUS Liberte stent
Interventions/Control_2
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
21 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patints with chronic renal failure on hemodialysis
Elective PCI for Ischemic heart disease using TAXUS Liberte stent
Key exclusion criteria CPA
Cardiogenic shock
Emergent PCI
STEMI
Intolerance with antiplatelet therapy
Planned PCI for other lesions in 6 months
Restenosis after DES
Severe valvular heart disease
Critical limb ischemia
CTO
No indication for PCI
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Kozuma
Organization Teikyo University Hospital
Division name Cardiology
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo
TEL 03-3964-1211
Email PXE00364@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Hitomi Usui
Organization Teikyo University Hospital
Division name Cardiology
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo
TEL 03-3964-1211
Homepage URL
Email PXE00364@nifty.com

Sponsor
Institute Coronary Intervention Trial and Evaluation group
Institute
Department

Funding Source
Organization Coronary Intervention Trial and Evaluation group
Organization
Division
Category of Funding Organization Self funding
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 東海大学医学部附属病院(神奈川県)、虎の門病院(東京都)、仙台厚生病院(宮城県)、光晴会病院(長崎県)、東京慈恵会医科大学附属 柏病院(千葉県)、板橋中央総合病院(東京都)、自治医科大学附属病院(栃木県)、横浜市立大学附属市民総合医療センター(神奈川県)、 東海大学八王子病院(東京都)、帝京大学医学部附属病院(東京都)、所沢ハートクリニック(埼玉県)、岩槻南病院(埼玉県)、三井記念病院(東京都)、あかね会土谷総合病院(広島県),兵庫医科大学病院(兵庫県)、石心会狭山病院(埼玉県)、小倉記念病院(福岡県)、青森県立中央病院(青森県)、福岡赤十字病院(福岡県)、菊名記念病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 07 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
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 Main results already published
Date of protocol fixation
2009 Year 08 Month 11 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2013 Year 10 Month 01 Day
Date of closure to data entry
2014 Year 10 Month 07 Day
Date trial data considered complete
2014 Year 10 Month 07 Day
Date analysis concluded
2014 Year 10 Month 07 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 07 Day
Last modified on
2014 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003168

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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