UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009179 |
|---|---|
| Receipt number | R000010405 |
| Scientific Title | Efficacy and Safety of StENt-assisted treatment for CErebral aneurysms |
| Date of disclosure of the study information | 2012/10/24 |
| Last modified on | 2012/10/24 04:42:56 |
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Basic information
Public title
Efficacy and Safety of StENt-assisted treatment for CErebral aneurysms
Acronym
ESSENCE
Scientific Title
Efficacy and Safety of StENt-assisted treatment for CErebral aneurysms
Scientific Title:Acronym
ESSENCE
Region
| Japan |
Condition
Condition
Intracranial aneurysm
Classification by specialty
| Radiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of stent assisted embolization of intracranial aneurysm
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
death, stroke and hemorrhagic event within 2-years after treatment
Key secondary outcomes
1. death, stroke, hemorrhagic event within 30days or between 31days to 2years after treatment
2. any change of anti-thrombotic therapy within 2years after treatment
3. recanalization or re-treatment within 2years after treatment
4. stent stenosis or occlusion within 2years after treatment
5. any adverse event within 2years after treatment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. stent assisted embolization of intracranial aneurysm
2. 20 or more years old
Key exclusion criteria
not decided
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Sakai |
Organization
Kobe City Medical Center General Hospital
Division name
Neurosurgery
Zip code
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL
078-302-4321
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Sakai |
Organization
Kobe City Medical Center general Hospital
Division name
Neurosurgery
Zip code
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL
078-302-4321
Homepage URL
Sponsor or person
Institute
Translational Research Informatics, Foundation for Biomedical Research and Innovation
Institute
Department
Personal name
Funding Source
Organization
Foundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization
Non profit foundation
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
神戸市立医療センター中央市民病院、先端医療センター、中村記念病院、仙台医療センター、広南病院、新潟大学、富山大学、獨協医科大学越谷病院、順天堂大学、虎の門病院、東京医科歯科大学、千葉大学、千葉県救急医療センター、名古屋大学、岐阜大学、京都大学、大阪大学、国立循環器病研究センター、岡山大学、徳島大学、鳥取大学、山口大学、小倉記念病院、久留米大学、福岡大学、福岡大学筑紫病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 24 | 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
| 2012 | Year | 08 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
To evaluate stent assisted embolization of intracranial aneurysm, record information about treatment and any event prospectively.
Management information
Registered date
| 2012 | Year | 10 | Month | 24 | Day |
Last modified on
| 2012 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010405
| 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 |
