UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054843 |
|---|---|
| Receipt number | R000062059 |
| Scientific Title | Japanese Registry of Intracranial Artery Stenosis |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/01/22 13:59:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Japanese Registry of Intracranial Artery Stenosis
Acronym
ICAS-Japan Registry
Scientific Title
Japanese Registry of Intracranial Artery Stenosis
Scientific Title:Acronym
ICAS-Japan Registry
Region
| Japan |
Condition
Condition
Intracranial Artery Stenosis
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the clinical characteristics and outcomes of the patients with intracranial artery stenosis (ICAS).
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to investigate the differences of the patient characteristics, treatment and outcomes between the patients with symptomatic and asymptomatic ICAS.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ischemic stroke during observation period
Key secondary outcomes
1) Cerebral infarction during observation period
2) TIA during observation period
3) Cerebral hemorrhage during observation period
4) Ischemic events during observation period
5) Hemorrhagic events during observation period
6) All cause death during observation period
7) Additional endovascular treatment or surgery during observation period
8) Asymptomatic cerebral infarction during observation period
9) Progression of stenosis during observation period
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with ICAS (50% or more stenosis).
Key exclusion criteria
1) Patients with ICAS caused by a non-atherosclerotic etiology such as moyamoya disease, arterial dissection, RCVS (reversible cerebral vasoconstriction syndrome), or vasculitis.
2) Patients diagnosed with intracranial artery occlusion.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Yoshimura |
Organization
Hyogo Medical University
Division name
Department of Neurosurgery
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo
TEL
0798-45-6455
s-yoshi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Uchida |
Organization
Hyogo Medical University
Division name
Department of Neurosurgery
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo
TEL
0798-45-6458
Homepage URL
kuchida@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical 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
Hyogo Medical University
Address
1-1 Mukogawa, Nishinomiya, Hyogo
Tel
0798-45-6111
rinri@hyo-med.ac.jp
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
| 2024 | Year | 07 | Month | 01 | 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
| 2024 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2024 | Year | 07 | Month | 01 | Day |
Last modified on
| 2025 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062059
