UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063247 |
|---|---|
| Receipt number | R000072305 |
| Scientific Title | Prospective study of transcranial Doppler monitoring after flow diverter placement for intracranial aneurysms |
| Date of disclosure of the study information | 2026/10/15 |
| Last modified on | 2026/10/14 16:50:54 |
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Basic information
Public title
Study of blood flow changes measured by transcranial Doppler ultrasonography after flow diverter treatment for intracranial aneurysms
Acronym
TCD Monitoring After Flow Diverter Treatment
Scientific Title
Prospective study of transcranial Doppler monitoring after flow diverter placement for intracranial aneurysms
Scientific Title:Acronym
TCD Monitoring After Flow Diverter Placement
Region
| Japan |
Condition
Condition
Intracranial aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To characterize longitudinal changes in middle cerebral artery blood flow velocity measured by transcranial Doppler ultrasonography before and after flow diverter placement and to explore their associations with postoperative clinical findings, imaging findings, and hemorrhagic and ischemic complications.
Basic objectives2
Others
Basic objectives -Others
To characterize longitudinal changes in middle cerebral artery blood flow velocity measured by transcranial Doppler ultrasonography before and after flow diverter placement.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Longitudinal change in transcranial Doppler measured mean blood flow velocity in the middle cerebral artery on the treated side relative to the preprocedural value.
Key secondary outcomes
Postoperative headache and other neurological findings; brain MRI findings, including ischemic lesions; hemorrhagic and ischemic complications; and exploratory associations of these findings with transcranial Doppler measures.
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Transcranial Doppler ultrasonography is performed before flow diverter placement (the preceding day), immediately after the procedure, on postoperative day 1, and during subsequent hospitalization. The bilateral middle cerebral arteries are assessed when feasible. Brain MRI is performed on postoperative day 1 and repeated if new symptoms or other clinical changes occur during follow-up. Flow diverter placement is clinically planned; no research-based allocation of treatment is described.
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
Patients scheduled for flow diverter placement for an intracranial aneurysm.
Patients who provide consent to participate in the study
Key exclusion criteria
Patients in whom blood flow velocity in the target vessel cannot be measured using transcranial Doppler ultrasonography.
Patients considered unsuitable for study participation by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Yonenaga |
Organization
Ichinomiya Nishi Hospital
Division name
Department of Neurosurgery
Zip code
494-0001
Address
1 Hira, Kaimei, Ichinomiya, Aichi, Japan
TEL
09067786849
h04m107935@gmail.com
Public contact
Name of contact person
| 1st name | MASANORI |
| Middle name | |
| Last name | YONENAGA |
Organization
Ichinomiya Nishi Hospital
Division name
Department of Neurosurgery
Zip code
494-0001
Address
1 Hira, Kaimei, Ichinomiya, Aichi, Japan
TEL
0586480077
Homepage URL
h04m107935@gmail.com
Sponsor or person
Institute
Ichinomiya Nishi Hospital
Institute
Department
Personal name
Masanori Yonenaga
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
Ichinomiya Nishi Hospital
Address
1 Hira, Kaimei, Ichinomiya, Aichi, Japan
Tel
0586-48-0077
h04m107935@gmail.com
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
| 2026 | Year | 10 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 12 | Day |
Last modified on
| 2026 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072305
