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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023703
Receipt No. R000027296
Scientific Title Proposal of a new criteria for Calcified SFA disease with multi modality evaluation
Date of disclosure of the study information 2016/08/20
Last modified on 2018/02/20

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Basic information
Public title Proposal of a new criteria for Calcified SFA disease with multi modality evaluation
Acronym CODE-J study
Scientific Title Proposal of a new criteria for Calcified SFA disease with multi modality evaluation
Scientific Title:Acronym CODE-J study
Region
Japan

Condition
Condition de novo SFA symptomatic lesions who had successfully undergone EVT
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigated calcified pattern in SFA by using Fluoroscopy, Angiography and Intra vascular ultrasound (IVUS).
Basic objectives2 Others
Basic objectives -Others Cross Sectional Study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluations of SFA lesion calcification in real world patients by 1.Fluoroscopy
2.Angiography (QVA) 3. Intra vascular ultrasound (IVUS)

Key secondary outcomes Comparision with historical data
The predictive factors of severe calcification

Base
Study type Others,meta-analysis etc

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria de novo SFA symptomatic lesions patients who had successfully undergone EVT
Key exclusion criteria with CFA, POPA lesion
In stent restenosis
Target sample size 140

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

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

Sponsor
Institute Kishiwada Tokushukai Hospital, Osaka, Japan
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
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 済生会中津病院 循環器内科 上月周
京都第二日赤病院 循環器科 椿本恵則
森ノ宮病院 循環器 福永匡史
新古賀病院 新谷嘉章
大阪府立急性期医療センター 岩崎祐介
宮崎市郡医師会病院 仲間達也

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

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
2014 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 01 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 Multi center cross sectional study

Management information
Registered date
2016 Year 08 Month 20 Day
Last modified on
2018 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027296

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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