UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040734 |
|---|---|
| Receipt number | R000045585 |
| Scientific Title | Fukushima Large Vessel Occlusion Stroke Registry |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2026/05/21 14:02:26 |
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Basic information
Public title
Fukushima Large Vessel Occlusion Stroke Registry
Acronym
Fukushima LVO Registry
Scientific Title
Fukushima Large Vessel Occlusion Stroke Registry
Scientific Title:Acronym
Fukushima LVO Registry
Region
| Japan |
Condition
Condition
Acute cerebral major artery occlusion
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to understand the status of treatment for acute cerebral major artery occlusion in Fukushima Prefecture and verify that mechanical thrombectomy is being performed appropriately.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)modified Rankin Scale at 90 days after onset
2)Symptomatic intracranial hemorrhage
Key secondary outcomes
1)Successful recanalization
2)The time required from the onset to the successful recanalization
3)Death within 90 days after onset
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
For patients who meet the following criteria 1) and 2), and for patients who fall under any of 3) from 6).
1)Acute ischemic stroke patients who hospitalized in Fukushima Prefecture within 24 hours from the onset or last known well.
2)Patients with acute intracerebral major vessel occlusion confirmed by CTA, MRA, or cerebral angiography.
3)Patients who underwent mechanical thrombectomy.
4)Patients with other occlusions besides ICA or M1 proximal portion.
5)Patients whose NIHSS is below 6 points.
6Patients whose CT or DWI-ASPECTS is below 6 points.
Key exclusion criteria
1)Patients considered inappropriate to participate in the study.
2)Patients with intraoperative stroke onset.
3)Patients with recurrent acute intracerebral major vessel occlusion.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Saito |
Organization
Fukushima Medical University
Division name
Department of Neurosurgery
Zip code
9601295
Address
1 Hikarigaoka, Fukushima, Japan
TEL
0245471266
kiyoshis@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Kojima |
Organization
Fukushima Medical University
Division name
Department of Neurosurgery
Zip code
9601295
Address
1 Hikarigaoka, Fukushima, Japan
TEL
0245471268
Homepage URL
neuro-s@fmu.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Fukushima Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1 Hikarigaoka, Fukushima, Japan
Tel
0245471825
rs@fmu.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
枡記念病院、総合南東北病院、福島赤十字病院、南相馬市立総合病院、太田西ノ内病院、公立藤田総合病院、南東北福島病院、星総合病院、寿泉堂綜合病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.cureus.com/articles/492267
Publication of results
Published
Result
URL related to results and publications
https://www.cureus.com/articles/492267
Number of participants that the trial has enrolled
217
Results
The median age was 81 years, and the median National Institutes of Health Stroke Scale (NIHSS) score was 18. At 90 days, functional independence (defined as a modified Rankin Scale [mRS] score of 0 to 2) was achieved in 68 patients (32.4%). Symptomatic intracranial hemorrhage occurred in 7 (3.3%), and 90-day mortality in 53 (25.2%). Successful reperfusion (defined as modified Thrombolysis in Cerebral Infarction [mTICI] 2b or 3) was achieved in 107 (72.8%).
Results date posted
| 2026 | Year | 05 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 05 | Month | 19 | Day |
Baseline Characteristics
The median age was 81 years (interquartile range [IQR], 73-88 years), and 111 patients (52.9%) were male. Premorbid functional independence was observed in 175 patients (83.3%). The median NIHSS score on admission was 18 (IQR, 13-24), and the median ASPECTS or pc-ASPECTS was 9 (IQR, 7-10). The most common site of occlusion was the M1 segment of the middle cerebral artery (43.8%), followed by the intracranial internal carotid artery (14.8%). Cardioembolism was the predominant stroke subtype, observed in 72.9% of patients. Intravenous rt-PA was administered to 99 patients (47.1%), and mechanical thrombectomy was performed in 147 (70.0%). Workflow metrics showed a median onset-to-door time of 88.5 minutes (IQR, 50-220 minutes) and door-to-imaging time of 40 minutes (IQR, 28-59 minutes). Among patients treated with mechanical thrombectomy, the median puncture-to-recanalization time was 58.5 minutes (IQR, 36-84 minutes), while the median onset-to-recanalization time was 267 minutes (IQR, 201-372.5 minutes).
Participant flow
A total of 217 patients were registered, of whom 210 were included in the final analysis after excluding incomplete cases. Among them, 147 (70.0%) underwent mechanical thrombectomy, while 63 (30.0%) received medical treatment, including intravenous thrombolysis.
Adverse events
No adverse events
Outcome measures
Primary outcome: Functional independence at 90 days was achieved in 68 patients (32.4%), and symptomatic intracranial hemorrhage within 72 h occurred in 7 patients (3.3%).
Secondary outcome: Among 147 patients treated with mechanical thrombectomy, successful reperfusion was achieved in 107 patients (72.8%), with a median onset-to-recanalization time of 267 minutes (IQR, 201-372.5 minutes). 90-day mortality occurred in 53 patients (25.2%).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
Primary outcomes
1)modified Rankin Scale at 90 days after onset
2)Symptomatic intracranial hemorrhage
Management information
Registered date
| 2020 | Year | 06 | Month | 12 | Day |
Last modified on
| 2026 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045585
