UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002594 |
|---|---|
| Receipt number | 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 15:05:49 |
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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
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
PXE00364@nifty.com
Sponsor or person
Institute
Coronary Intervention Trial and Evaluation group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003168
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| Registered date | File name |
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