UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031187 |
|---|---|
| Receipt number | R000035606 |
| Scientific Title | Evaluation of carotid plaques by using Optical Frequency Domain Imaging (OFDI) in the patients who are scheduled for carotid endarterectomy |
| Date of disclosure of the study information | 2018/02/11 |
| Last modified on | 2018/02/07 17:41:34 |
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Basic information
Public title
Evaluation of carotid plaques by using Optical Frequency Domain Imaging (OFDI) in the patients who are scheduled for carotid endarterectomy
Acronym
Evaluation of carotid plaques by using Optical Frequency Domain Imaging (OFDI) in the patients who are scheduled for carotid endarterectomy
Scientific Title
Evaluation of carotid plaques by using Optical Frequency Domain Imaging (OFDI) in the patients who are scheduled for carotid endarterectomy
Scientific Title:Acronym
Evaluation of carotid plaques by using Optical Frequency Domain Imaging (OFDI) in the patients who are scheduled for carotid endarterectomy
Region
| Japan |
Condition
Condition
Carotid artery stenosis
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the association between carotid plaque pathology and plaque feature of using OFDI in the patients with carotid artery stenosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Not setting
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
FASTVIEW (catheter), TERUMO
LUNAWAVE (ODFI system), TERUMO
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) the patients who have carotid artery stenosis
2) Age over 20 y.o, under 80 y.o
3) the rate of carotid stenotic lesion was over 50% in symptomatic carotid artery stenosis. or the rate of carotid stenotic lesion was over 80% in asymptomatic carotid artery stenosis
4) The modified Rankin Scale is 0, 1, or 2 before carotid endarterectomy
5) Consented to this study from the patient or family
Key exclusion criteria
1 ) high risk of carotid endarterectomy (Ischemic stroke within previous 48 hr, Presence of intraluminal thrombus, Total occlusion of target vessel, Vascular disease precluding use of catheter-based techniques, Intracranial aneurysm >9 mm in diameter
Need for more than two stents, History of bleeding disorder, Percutaneous or surgical intervention planned within next 30 days, Life expectancy <1 yr
Ostial lesion of common carotid artery or brachiocephalic artery
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Yoshimura |
Organization
Department of Neurosurgery, Hyogo College of Medicine, Nishinomiya, Japan
Division name
Department of Neurosurgery
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan 663-8501
TEL
81-798-45-6455
mmao04211075@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyofumi Yamada |
Organization
Department of Neurosurgery, Hyogo College of Medicine, Nishinomiya, Japan
Division name
Department of Neurosurgery
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan 663-8501
TEL
81-798-45-6455
Homepage URL
yamadakiyofumi@gmail.com
Sponsor or person
Institute
Department of Neurosurgery, Hyogo College of Medicine, Nishinomiya, 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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 07 | Day |
Last modified on
| 2018 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035606
