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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010373
Receipt No. R000012138
Scientific Title Direct endvascular thrombectomy for acute internal carotid artery occlusion
Date of disclosure of the study information 2013/03/31
Last modified on 2014/09/30

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Basic information
Public title Direct endvascular thrombectomy for acute internal carotid artery occlusion
Acronym Direct thrombectomy of acute ICA occlusion
Scientific Title Direct endvascular thrombectomy for acute internal carotid artery occlusion
Scientific Title:Acronym Direct thrombectomy of acute ICA occlusion
Region
Japan

Condition
Condition acute ICA occlusive ischemic stroke within 3.5 hours from oncet
Classification by specialty
Neurology Vascular surgery Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We clarify whether direct endvascular thrombectomy is more effective than combination therapy of intravenous t-PA and endvascular thrombectomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the modified Rankin Scale at three-months and categorized as favourable (modified Rankin Scale 0-2)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 To recanalize for acue ICA occlusion,
direct endovascular thrombectomy is performed.
Interventions/Control_2 First intravenous t-PA therapy is performed, and if neurological sign is not improved after 30 minutes, endvascular thrombectomy is performed.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Ischemic stroke within 3.5 hours from symptoms onset
2.Acute ICA occlusion on MRI
3.Patients are defined as eligible to receive intravenous t-PA therapy.
Key exclusion criteria 1.The agreement of a patient or the family is not provided.
2.MRI is impossible.
3.Endovascular therapy is impossible.
4.Intravenous t-PA therapy is contraindicated.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Inoue
Organization Kawasaki Medical School
Division name Stroke Medicine
Zip code
Address 577, Matsushima, Kurashiki-city Okayama
TEL 086-462-1111
Email inouet@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Inoue
Organization Kawasaki Medical School
Division name Stroke Medicine
Zip code
Address 577, Matsushima, Kurashiki-city Okayama
TEL 086-462-1111
Homepage URL
Email inouet@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 03 Month 31 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
2013 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 31 Day
Last modified on
2014 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012138

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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