UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043265 |
|---|---|
| Receipt number | R000049382 |
| Scientific Title | Antiplatelet therapy in neck-remodeling device-assisted endovascular treatment for intracranial aneurysms, a multi center cohort study |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2023/11/06 21:27:33 |
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Basic information
Public title
Antiplatelet therapy in neck-remodeling device-assisted endovascular treatment for intracranial aneurysms, a multi center cohort study
Acronym
Antiplatelet therapy in neck-remodeling device-assisted endovascular treatment for intracranial aneurysms, a multi center cohort study
Scientific Title
Antiplatelet therapy in neck-remodeling device-assisted endovascular treatment for intracranial aneurysms, a multi center cohort study
Scientific Title:Acronym
Antiplatelet therapy in neck-remodeling device-assisted endovascular treatment for intracranial aneurysms, a multi center cohort study
Region
| Japan |
Condition
Condition
unruptured intracranial aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the optimal regimen of antiplatelet therapy in neuroendovascular treatment for cerebral aneurysms
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time from endovascular treatment to onset of thromboembolic events related to target vessels, or death
Key secondary outcomes
1) hemorrhagic events equivalent to ISTH major bleeding
2) hemorrhagic events which required intervention by a medical professional
3) asymptomatic ischemic lesion on MRI-DWI
4) Ischemic event other than cerebrovascular disease
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
1)Patients with unruptured cerebral aneurysm over 20 years old
2) Patients who received stent-assisted neuroendovascular treatment for unruptured cerebral aneurysm from January 1, 2010 to December 31, 2020.
3) Patients who received periprocedural dual antiplatelet therapy
Key exclusion criteria
(1) Patients who could not receive sufficient preoperative antiplatelet therapy due to emergency treatment for ruptured cerebral aneurysm, symptomatic cerebral aneurysm, etc.
(2) In addition, patients who are judged to be inappropriate as targets by the judgment of the investigator.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Enomoto |
Organization
Gifu Univeristy Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
5011194
Address
1-1 Yanagido, Gifu city, GIFU
TEL
0582306271
enomoto@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | hirofumi |
| Middle name | |
| Last name | Matsubara |
Organization
Gifu Univeristy Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
5011194
Address
1-1 Yanagido, Gifu city, GIFU
TEL
0582306271
Homepage URL
hrfm.matsubara@gmail.com
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Gifu Univeristy IRB
Address
1-1 Yanagido, Gifu city, GIFU
Tel
05802306059
rinri@gifu-u.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
| 2025 | Year | 04 | 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
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data will be stored in EDC system.
Management information
Registered date
| 2021 | Year | 02 | Month | 06 | Day |
Last modified on
| 2023 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049382
