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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004425
Receipt No. R000005284
Scientific Title Retrospective Analysis for Femoropopliteal Stenting of 1000 limbs
Date of disclosure of the study information 2010/10/21
Last modified on 2010/10/21

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Basic information
Public title Retrospective Analysis for Femoropopliteal Stenting of 1000 limbs
Acronym REAL-FP1000
Scientific Title Retrospective Analysis for Femoropopliteal Stenting of 1000 limbs
Scientific Title:Acronym REAL-FP1000
Region
Japan

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

Objectives
Narrative objectives1 To investigate the safety and efficasy of self-expandable nitinol stent for femoropopliteal artery disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes primary patency (incidence of in-stent restenosis)in patients with and without cilostazol, chronic total occlusion or hemodialysis.
Angiographic patterns of in-stent restenosis
Key secondary outcomes Secondary patency (re-occlusion 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 patients who underwent successful EVT with a nitinol stent for de novo lesions
Key exclusion criteria balloon angioplasty alone, restenotic lesions, use of a metallic stent, acute or subacute limb ischemia or history of lower extremities bypass surgery or endovascular treatment
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshimitsu Soga
Organization Kokura Memorial ospital
Division name cardiology
Zip code
Address 1-1 Kifune-machi Kokurakita-ku Kitakyushu
TEL 093-921-2231
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kokura Memorial Hospital
Division name cardiology
Zip code
Address
TEL 093-921-2231
Homepage URL
Email

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 小倉記念病院、関西労災病院、横浜市東部病院、仙台厚生病院

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 21 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
2010 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information mean follow-up was 23 months

Management information
Registered date
2010 Year 10 Month 21 Day
Last modified on
2010 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005284

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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