UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004860 |
|---|---|
| Receipt number | R000005661 |
| Scientific Title | A study of the endovascular treatment for the main artery occlusion after intravenous t-PA treatment |
| Date of disclosure of the study information | 2011/02/01 |
| Last modified on | 2018/09/12 17:36:29 |
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Basic information
Public title
A study of the endovascular treatment for the main artery occlusion after intravenous t-PA treatment
Acronym
A study of the endovascular treatment after intravenous t-PA treatment
Scientific Title
A study of the endovascular treatment for the main artery occlusion after intravenous t-PA treatment
Scientific Title:Acronym
A study of the endovascular treatment after intravenous t-PA treatment
Region
| Japan |
Condition
Condition
Cerebral infarction within onset three hours
Classification by specialty
| Cardiology | Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate whether recanalization therapy by the endovascular treatment is useful in a patients with cerebral infarcition for hyper-acute phase.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of patients that modified Rankin's scale onset three months later is 0 to 2.
Key secondary outcomes
Symptomatic intracranial hemorrhage within onset of 24 hours
Death within onset three months
Presence of recanalization just after the endovascular treatment
NIHSS score: after treatment of 24 hours, 7days, and discharge
Other adverse effect
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
endovascular treatment
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
A case with main cerebral artery (ICA, MCA, VA, BA) occlusion who has administered iv-tPA within three hours onset
Key exclusion criteria
The patient having contrast media allergy
contraindication for iv-tPA treatment
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Watanabe |
Organization
Kawasaki Medical School
Division name
Department of stroke medicine
Zip code
Address
577 Matsushima, Kurashiki city, Okayama, Japan
TEL
086-462-1111
masao-w@par.odn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masao Watanabe |
Organization
Kawasaki Medical School
Division name
Department of stroke medicine
Zip code
Address
577 Matsushima, Kurashiki city, Okayama, Japan
TEL
086-462-1111
Homepage URL
masao-w@par.odn.ne.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
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
川崎医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | 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
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 16 | Day |
Date of closure to data entry
| 2011 | Year | 02 | Month | 16 | Day |
Date trial data considered complete
| 2011 | Year | 02 | Month | 16 | Day |
Date analysis concluded
| 2011 | Year | 02 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 12 | Day |
Last modified on
| 2018 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005661
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
