UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006684 |
|---|---|
| Receipt number | R000007898 |
| Scientific Title | Outcome in Hemodialysis of Promus stent |
| Date of disclosure of the study information | 2011/11/08 |
| Last modified on | 2015/05/07 13:35:16 |
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Basic information
Public title
Outcome in Hemodialysis of Promus stent
Acronym
OUCH-PRO
Scientific Title
Outcome in Hemodialysis of Promus stent
Scientific Title:Acronym
OUCH-PRO
Region
| Japan |
Condition
Condition
Ischemic heart disease
Chronic renal failure on hemodialysis
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the hemodialysis patient's outcome undergoing coronaru intervention using Promus 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 including cardiac death, myocardial infarction in the target vessel and target vessel revascularization 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
osteoprotegerin 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
| Medicine |
Interventions/Control_1
PCI with Promus 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 Promus 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 | Yuji Ikari |
Organization
Tokai University
Division name
Cardiovascular Medicine
Zip code
Address
143 Shimokasuya Isehara 259-1193, Japan
TEL
0463-93-1121
ikari@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachiko Yajima |
Organization
Tokai University
Division name
Cardiovascular Medicine
Zip code
Address
143, Shimokasuya, Isehara
TEL
0463-93-1121
Homepage URL
s.yajima@tokai-u.jp
Sponsor or person
Institute
Coronary Intervention Trial and Evaluation group
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 07 | Day |
Last modified on
| 2015 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007898
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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