UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010373 |
|---|---|
| Receipt number | 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 09:40:42 |
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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
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
inouet@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012138
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
