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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010986
Receipt No. R000012860
Scientific Title Multicenter Retorospective analysisfor femoropopliteal lesion 2012
Date of disclosure of the study information 2013/06/20
Last modified on 2013/06/17

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Basic information
Public title Multicenter Retorospective analysisfor femoropopliteal lesion 2012
Acronym REAL-FP 2012
Scientific Title Multicenter Retorospective analysisfor femoropopliteal lesion 2012
Scientific Title:Acronym REAL-FP 2012
Region
Japan

Condition
Condition peripheral artery disease for lower extremities
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 safety and efficasy of endovascular therapy for femoropopliteal artery disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 30-day mortality
complication
primary patency
Key secondary outcomes assisted-primary patency
secondary patency
overall survival
limb salvage rate
amputation-free survival

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 de novo femoropopliteal artery disease
Key exclusion criteria acute onset ischemia
histry of revascularization
asymptomatic
unknown symptom
Target sample size 2500

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
TEL +81-93-511-2000
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kokura Memorial Hospital
Division name Cardiology
Zip code
Address 3-2-1 Asano Kokurakita-ku Kitakyushu city
TEL
Homepage URL
Email

Sponsor
Institute Kokkura Memorial Hospital
Institute
Department

Funding Source
Organization Kokkura 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
2013 Year 06 Month 20 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
2012 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
2012 Year 09 Month 01 Day
Date trial data considered complete
2012 Year 10 Month 01 Day
Date analysis concluded

Other
Other related information 30-day mortality 1.1%
complication rate 7.8%
5-year primary patency 52.9%

Management information
Registered date
2013 Year 06 Month 17 Day
Last modified on
2013 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012860

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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