UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002808 |
|---|---|
| Receipt number | R000003306 |
| Scientific Title | Clinical study regarding carotid plaque imaging using optical coherence tomography (OCT) |
| Date of disclosure of the study information | 2009/11/27 |
| Last modified on | 2009/11/27 23:09:04 |
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Basic information
Public title
Clinical study regarding carotid plaque imaging using optical coherence tomography (OCT)
Acronym
Carotid plaque imaging using OCT
Scientific Title
Clinical study regarding carotid plaque imaging using optical coherence tomography (OCT)
Scientific Title:Acronym
Carotid plaque imaging using OCT
Region
| Japan |
Condition
Condition
carotid artery stenosis
Classification by specialty
| Cardiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Optical coherence tomography (OCT) was developed recently, and reported to have better resolving power than intravascular ultrasound. The aim of this study is to know the safety and efficacy of plaque imaging using OCT during carotid artery stenting.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Successful plaque imaging using OCT
Key secondary outcomes
Neurological event during OCT imaging
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
The patient who receives carotid artery stenting using proximal protection method
Key exclusion criteria
The patient who shows ischemic symptom during carotid artery occlusion
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Yoshimura |
Organization
Graduate School of Medicine, Gifu University
Division name
Department of Neurosurgery
Zip code
Address
1-1 Yanagido, Gifu city, Gifu, Japan
TEL
+81-58-230-6271
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Yoshimura |
Organization
Graduate School of Medicine, Gifu University
Division name
Department of Neurosurgery
Zip code
Address
1-1 Yanagido, Gifu city, Gifu, Japan
TEL
+81-58-230-6271
Homepage URL
s-yoshi@gifu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Gifu University
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
岐阜大学医学部附属病院（岐阜市）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Using intravascular OCT imaging system, plaque images are obtained during carotid artery stenting procedure. The findings of OCT imaging are compared with those of the other imaging systems such as IVUS.
Management information
Registered date
| 2009 | Year | 11 | Month | 27 | Day |
Last modified on
| 2009 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003306
