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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006684
Receipt No. 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

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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
Email 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
Email s.yajima@tokai-u.jp

Sponsor
Institute Coronary Intervention Trial and Evaluation group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007898

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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