UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023703 |
|---|---|
| Receipt number | 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 10:14:31 |
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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
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
masahiko-fujihara@themis.ocn.ne.jp
Sponsor or person
Institute
Kishiwada Tokushukai Hospital, Osaka, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027296
