UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002038 |
|---|---|
| Receipt number | R000002490 |
| Scientific Title | intra-arterial thrombolysis for acute cerebral major vessel occlusion with unknown onset |
| Date of disclosure of the study information | 2009/06/04 |
| Last modified on | 2021/05/20 16:04:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
intra-arterial thrombolysis for acute cerebral major vessel occlusion with unknown onset
Acronym
intra-arterial thrombolysis for acute cerebral major vessel occlusion with unknown onset
Scientific Title
intra-arterial thrombolysis for acute cerebral major vessel occlusion with unknown onset
Scientific Title:Acronym
intra-arterial thrombolysis for acute cerebral major vessel occlusion with unknown onset
Region
| Japan |
Condition
Condition
acute cerebral major vessel occlusion
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of safety and efficacy for intra-arterial thrombolytic therapy for acute cerebral major vessel occlusion with unknown onset
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
recanalization rate
hemorrhagic complication
outcome after 1 month
Key secondary outcomes
other complications
outcome after 6 month
Base
Study type
Interventional
Study design
Basic design
expanded access
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
| Medicine | Maneuver |
Interventions/Control_1
intra-arterial thrombolysis using urokinase or percutaneous transluminal angioplasty for acute cerebral major vessel occlusion with unknown onset (2009.4.1-2012.3.1) but without evidence of cerebral infarction on CT or MRI
Interventions/Control_2
controls: the results from MELT-Japan study
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
acute cerebral major vessel occlusion with unknown onset (2009.4.1-2012.3.1) but without evidence of cerebral infarction on CT or MRI
Key exclusion criteria
Patient who did not obtain agreement for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Iwama |
Organization
Graduate School of Medicine, Gifu University
Division name
Neurosurgery
Zip code
Address
1-1 Yanagido, Gifu-city, Gifu, JAPAN
TEL
058-230-6271
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Yoshimura |
Organization
Graduate School of Medicine, GIfu University
Division name
Department of Neurosurgery
Zip code
Address
1-1, Yanagido, GIfu-city, Gifu, JAPAN
TEL
058-230-6271
Homepage URL
http://www.med.gifu-u.ac.jp/neurosurgery
s-yoshi@gifu-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Graduate School of Medicine, Gifu University
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2009 | Year | 06 | Month | 04 | 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
| 2009 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 03 | Day |
Last modified on
| 2021 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002490
