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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040734
Receipt No. R000045585
Scientific Title Fukushima Large Vessel Occlusion Stroke Registry
Date of disclosure of the study information 2020/07/01
Last modified on 2020/07/02

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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
Email 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
Email neuro-s@fmu.ac.jp

Sponsor
Institute Department of Neurosurgery, Fukushima Medical University
Institute
Department

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
Email 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
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 Enrolling by invitation
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 04 Month 30 Day
Date trial data considered complete
2023 Year 06 Month 30 Day
Date analysis concluded
2023 Year 09 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
2020 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045585

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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