UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025533 |
|---|---|
| Receipt number | R000029387 |
| Scientific Title | Morphological evaluation of the carotid artery lumen after CASPER stent placement using OFDI |
| Date of disclosure of the study information | 2017/01/05 |
| Last modified on | 2020/01/08 18:39:30 |
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Basic information
Public title
Morphological evaluation of the carotid artery lumen after CASPER stent placement using OFDI
Acronym
Morphological evaluation after CASPER stent placement using OFDI
Scientific Title
Morphological evaluation of the carotid artery lumen after CASPER stent placement using OFDI
Scientific Title:Acronym
Morphological evaluation after CASPER stent placement using OFDI
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 was to compare the rate and size of plaque protrusion between CASPER stent and conventional stents detected by OFDI and to evaluate the efficacy of CAS with CASPER stent for the cases with unstable plaque.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of plaque protrusion after CAS
Presence of new ischemic lesion of the brain after CAS
Neurological state at the 7days and 90days after CAS
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
CASPER stent (Terumo, Tokyo)
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
| 85 | years-old | >= |
Gender
Male
Key inclusion criteria
Patients who receive carotid artery stenting for the treatment of carotid artery stenosis.
Symptomatic patients with 50% or more stenosis.
Asymptomatic patients with 80% or more stenosis.
Key exclusion criteria
Patients who cannot receive carotid artery stenting
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Yoshimura |
Organization
Hyogo College of Medicine
Division name
Neurosurgery
Zip code
Address
1-1 Mukogawacho Nishinomiya Hyogo
TEL
0798-45-6455
shinichiyoshimura@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyofumi Yamada |
Organization
Hyogo College of Medicine
Division name
Neurosurgery
Zip code
Address
1-1 Mukogawacho Nishinomiya Hyogo
TEL
0798-45-6455
Homepage URL
yamadakiyofumi@gmail.com
Sponsor or person
Institute
Department of Neurosurgery, Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 01 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 05 | Day |
Last modified on
| 2020 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029387
