UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057450 |
|---|---|
| Receipt number | R000065646 |
| Scientific Title | A multicenter registry study investigating the long-term result after neuroendovascular intervention |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2026/05/01 14:51:16 |
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Basic information
Public title
A multicenter registry study investigating the long-term result after neuroendovascular intervention
Acronym
A multicenter registry study investigating the long-term result after neuroendovascular intervention
Scientific Title
A multicenter registry study investigating the long-term result after neuroendovascular intervention
Scientific Title:Acronym
A multicenter registry study investigating the long-term result after neuroendovascular intervention
Region
| Japan |
Condition
Condition
pathologies requiring neuroendovascular treatment
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the long-term safety and effectiveness of neuroendovascular therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
perioperative complication
Key secondary outcomes
1. symptomatic stroke events during the follow-up period
2. complete occlusion of the target lesions
3. recurrence of the target lesions
4. re-treatment of the target lesions
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients receiving neuroendovascular therapy at the participating centers during the study period.
Key exclusion criteria
those without adequate clinical and radiologial follow-up.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Nobuhito |
| Middle name | |
| Last name | Saito |
Organization
The University of Tokyo
Division name
Department of Neurosurgery
Zip code
1138655
Address
7-3-1, Hongo, Bunyko-ku, Tokyo
TEL
0338155411
nsaito-nsu@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Koizumi |
Organization
The University of Tokyo
Division name
Department of Neurosurgery
Zip code
1138655
Address
7-3-1, Hongo, Bunyko-ku, Tokyo
TEL
0338155411
Homepage URL
sakoizumi-tky@umin.net
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
none
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
Office for Human Research Studies(OHRS) , Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel
0338155411
ethics@m.u-tokyo.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 | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_his_list.cgi?recptno=R000065646
Publication of results
Partially published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_his_list.cgi?recptno=R000065646
Number of participants that the trial has enrolled
139
Results
119 FD-treated patients (2018-2024) had >= 3 months MRA follow-up. Occlusion rates at 3, 6, 12 months were 15%, 48%, 79%. Aneurysm diameter >= 10.9 mm predicted lower occlusion.
Results date posted
| 2026 | Year | 05 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 05 | Month | 01 | Day |
Baseline Characteristics
see above
Participant flow
asee above
Adverse events
not applicable
Outcome measures
see above
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2025 | Year | 03 | Month | 30 | Day |
Last modified on
| 2026 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065646
