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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040063
Receipt No. R000045682
Scientific Title Periodical difference of SFA intervention -Multi center retrospective analysis-
Date of disclosure of the study information 2020/04/10
Last modified on 2020/04/05

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Basic information
Public title Periodical difference of SFA intervention
-Multi center retrospective analysis-
Acronym MK4 study
Scientific Title Periodical difference of SFA intervention
-Multi center retrospective analysis-
Scientific Title:Acronym MK4 study
Region
Japan

Condition
Condition Symptomatic Superficial femoral artery (SFA) atherosclerosis occlusive disease
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the real-world endovascular treatment therapy for SFA AIOD
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary patency rate
Key secondary outcomes Free from target lesion revascularization rate, Amputation free rate, all-cause mortality 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 From 2010-2018,
Successfully EVT for SFA lesions
Rutherford category 2-4
de novo lesions
Key exclusion criteria Rutherford 5-6
In stent restenosis
Target sample size 2800

Research contact person
Name of lead principal investigator
1st name Masahiko
Middle name
Last name Fujihara
Organization Kishiwada Tokushukai Hospital
Division name Cardiology
Zip code 595-8522
Address 4-27-1,Kamori-cho,Kishiwada City Osaka,Japan
TEL 072-445-9915
Email masahiko-fujihara@themis.ocn.ne.jp

Public contact
Name of contact person
1st name Masahiko
Middle name
Last name Fujihara
Organization Kishiwada Tokushukai Hospital
Division name Cardiology
Zip code 595-8522
Address 4-27-1,Kamori-cho,Kishiwada City Osaka,Japan
TEL 072-445-9915
Homepage URL
Email masahiko-fujihara@themis.ocn.ne.jp

Sponsor
Institute Kishiwada Tokushukai Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kishiwada Tokushukai Hospital IRB
Address 4-27-1,Kamori-cho,Kishiwada City Osaka,Japan
Tel 072-445-9915
Email kenji.nakatani@tokushukai.jp

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 岸和田徳洲会病院、小倉記念病院、関西労災病院、森之宮病院、済生会中津病院 

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 2800
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 No longer recruiting
Date of protocol fixation
2019 Year 10 Month 31 Day
Date of IRB
2019 Year 10 Month 31 Day
Anticipated trial start date
2019 Year 10 Month 31 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multicenter retrospective observational analysis

Management information
Registered date
2020 Year 04 Month 05 Day
Last modified on
2020 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045682

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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