UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003638 |
|---|---|
| Receipt number | R000004393 |
| Scientific Title | Endovascular recanalization therapy for acute ischemic stroke |
| Date of disclosure of the study information | 2010/05/19 |
| Last modified on | 2016/11/22 15:51:16 |
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Basic information
Public title
Endovascular recanalization therapy for acute ischemic stroke
Acronym
Endovascular recanalization therapy for acute ischemic stroke
Scientific Title
Endovascular recanalization therapy for acute ischemic stroke
Scientific Title:Acronym
Endovascular recanalization therapy for acute ischemic stroke
Region
| Japan |
Condition
Condition
acute ischemic stroke
Classification by specialty
| Neurology | Radiology | Neurosurgery |
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the endovascular recanalization treatment for acute ischemic stroke
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recanalization rate
Key secondary outcomes
Clinical outcome
Rate of hemorrhagic infarction
Procedure related complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
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
(1)Patients without neurological improvement, and NIHSS>8points, no hemorrhage on CTscan after the completion of IV tPA
(2)Patients who are ineligible for IV tPA and meet all of the following criteria: age>18, NIHSS>8, < 6hours of stroke symptom onset,no or only subtle early ischemic signs on CTscan, mismatch of MRI-DWI and clinical symptoms.
Key exclusion criteria
(1)current pregnancy, (2) serum glucose>50mg/dl, (3)sustained systolic blood pressure>185mmHg despite treatment, (4)platelet count<30000, (5) INR>3.0, (6) history of severe allergy or severe renal failure which restrict the use of contrast media, (7) CT revealing significant mass effect with midline shift or hemorrhage, (8)informed consent is not obtained.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Ushikoshi |
Organization
Hokkaido Medical Center
Division name
Department of Neurosurgery
Zip code
Address
5-7, Yamanote, Sapporo, Japan
TEL
011-611-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Ushikoshi |
Organization
Hokkaido Medical Center
Division name
Department of Neurosurgery
Zip code
Address
5-7, Yamanote, Sapporo, Japan
TEL
011-611-8111
Homepage URL
Sponsor or person
Institute
Hokkaido Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
北海道医療センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 19 | 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
| 2010 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 19 | Day |
Last modified on
| 2016 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004393
