UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021091 |
|---|---|
| Receipt number | R000024328 |
| Scientific Title | Blood flow measurements before and after carotid artery stenting |
| Date of disclosure of the study information | 2016/02/28 |
| Last modified on | 2020/09/02 18:58:31 |
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Basic information
Public title
Blood flow measurements before and after carotid artery stenting
Acronym
Blood flow measurements before and after carotid artery stenting
Scientific Title
Blood flow measurements before and after carotid artery stenting
Scientific Title:Acronym
Blood flow measurements before and after carotid artery stenting
Region
| Japan |
Condition
Condition
carotid artery stenosis
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure blood flow volume rates of the bilateral internal carotid arteries and the basilar artery before and after carotid artery stenting and to elucidate time trend of total cerebral blood flow rate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood flow volume rates at three months after carotid artery stenting
Key secondary outcomes
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
Patient planned to undergo carotid artery stenting
Key exclusion criteria
Patient who refuses
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Tanaka |
Organization
Osaka University Graduate School of Medicine
Division name
Radiology
Zip code
Address
Yamadaoka 2-2, Suita, Osaka 565-0871, Japan
TEL
+81-6-6879-3434
tanaka@radiol.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Tanaka |
Organization
Osaka University, Graduate school of medicine
Division name
Radiology
Zip code
Address
Yamadaoka 2-2, Suita, Osaka 565-0871, Japan
TEL
+81-6-6879-3434
Homepage URL
tanaka@radiol.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University, Graduate school of medicine, Department of Radiology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 28 | 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
11
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 04 | Month | 11 | Day |
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 | 06 | Month | 11 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 09 | Month | 02 | Day |
Other
Other related information
To measure blood flow rate before and after carotid artery stenting.
Management information
Registered date
| 2016 | Year | 02 | Month | 18 | Day |
Last modified on
| 2020 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024328
