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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006032
Receipt No. R000007141
Scientific Title REtrospective multicentre AnaLysis for Aorto-Iliac stenting
Date of disclosure of the study information 2011/07/25
Last modified on 2011/10/03

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Basic information
Public title REtrospective multicentre AnaLysis for Aorto-Iliac stenting
Acronym REAL-AI
Scientific Title REtrospective multicentre AnaLysis for Aorto-Iliac stenting
Scientific Title:Acronym REAL-AI
Region
Japan

Condition
Condition Aortoiliac artery disease
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Safety and efficacy of primary stenting for aortoiliac artery disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes primary patency
Key secondary outcomes secondary patency
initial success rate, mortality, non-fatal myocardial infarction, stroke, amputation rate, revascularization rate

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Between January 2005 and Descenber 2009, elective primary stenting for de novo aortoiliac lesion.
Key exclusion criteria acute onset
rstenotic lesion
history of recanalization
asymptomatic
treatment by balloon angioplasty alone
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshimitsu Soga
Organization Kokura Memorial Hospital
Division name cardiology
Zip code
Address 3-2-1 Asano Kokurakita-ku Kitakyushu city Japan
TEL +81935112000
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kokura Memorial Hospital
Division name cardiology
Zip code
Address
TEL
Homepage URL
Email kmhptca@kokura-heart.com

Sponsor
Institute Kokura Memorial Hospital
Institute
Department

Funding Source
Organization Kokura Memorial Hospital
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

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 25 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 06 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2011 Year 08 Month 01 Day
Date of closure to data entry
2011 Year 09 Month 01 Day
Date trial data considered complete
2011 Year 10 Month 01 Day
Date analysis concluded
2011 Year 11 Month 01 Day

Other
Other related information trial was finished

Management information
Registered date
2011 Year 07 Month 24 Day
Last modified on
2011 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007141

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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