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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002726
Receipt No. R000003320
Scientific Title REtrospective multicenter AnaLysis for FemoroPopliteal stenting registry
Date of disclosure of the study information 2009/11/10
Last modified on 2009/11/08

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Basic information
Public title REtrospective multicenter AnaLysis for FemoroPopliteal stenting registry
Acronym REAL-FP
Scientific Title REtrospective multicenter AnaLysis for FemoroPopliteal stenting registry
Scientific Title:Acronym REAL-FP
Region
Japan

Condition
Condition Peripheral artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the primary patency after femoropopliteal stenting
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patency
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Nitinol 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with peripheral artery disease who underwent successful EVT with nitinol stents for de novo femoropopliteal artery
Key exclusion criteria None
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Iida
Organization Kansai Rosai Hospital
Division name Cardiovascular center
Zip code
Address 3-1-69, Inabaso, Amagasaki city, Hygo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kansai Rosai Hospital
Division name Cardiovascular center
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Kansai Rosai Hospital, Cardiovascular Center
Institute
Department

Funding Source
Organization None
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 関西労災病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 10 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
2003 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2003 Year 12 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 08 Day
Last modified on
2009 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003320

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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