UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010342 |
|---|---|
| Receipt number | R000012098 |
| Scientific Title | Efficacy of HydroSoft coil on endovascular treatment for intracranial aneurysms; Multi-center, prospective, registry trial |
| Date of disclosure of the study information | 2013/03/28 |
| Last modified on | 2013/03/28 18:22:15 |
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Basic information
Public title
Efficacy of HydroSoft coil on endovascular treatment for intracranial aneurysms;
Multi-center, prospective, registry trial
Acronym
Japanese HydroSoft Registry (JHSR)
Scientific Title
Efficacy of HydroSoft coil on endovascular treatment for intracranial aneurysms;
Multi-center, prospective, registry trial
Scientific Title:Acronym
Japanese HydroSoft Registry (JHSR)
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 endovascular treatment using HydroSoft coil for intracranial aneurysm embolization
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Recanalization of endovascular treatment using HydroSoft coil within 1 year
Key secondary outcomes
1) Rebleeding after endovascular treatment using HydroSoft coil within 1 year
2) Major adverse event and death after endovascular treatment using HydroSoft coil within 30 days
3) Retreatment of aneurysm after endovascular treatment using HydroSoft coil within 1 year
4) Any stroke after endovascular treatment using HydroSoft coil within 1 year
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are 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 using HydroSoft coil
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) saccular aneurysm
2) unruptured aneurysm or chronic ruptured aneurysm or acute ruptured aneurysm with WFNS Grade I to III
3) maximum diameter 10mm or less
4) HydroSoft coil 50% or more length used
5) 1 year follow-up possible
Key exclusion criteria
1) previously receive endovascular treatment
2) another aneurysm planned to endovascular treatment
Target sample size
120
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 | Chiaki Sakai |
Organization
Institute of Biomedical Research and Innovation
Division name
Neuroendovascular
Zip code
Address
2-2 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL
078-304-520
Homepage URL
ibri-net@fbri.org
Sponsor or person
Institute
Translational Research Informatics
Institute
Department
Personal name
Funding Source
Organization
Foundation of 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（兵庫県）、中村記念病院（北海道）、広南病院（宮城県）、仙台医療センター（宮城県）、新潟大学（新潟県）、獨協医科大学越谷病院（埼玉県）、虎の門病院（東京都）、順天堂大学（東京都）、名古屋大学（愛知県）、岐阜大学（岐阜県）、三重大学（三重県）、富山大学（富山県）、金沢大学（石川県）、京都大学（京都府）、大阪大学（大阪府）、岡山大学（岡山県）、香川大学（香川県）、徳島大学（徳島県）、山口大学（山口県）、小倉記念病院（福岡県）、九州医療センター（福岡県）、福岡大学（福岡県）、久留米大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 28 | Day |
Last modified on
| 2013 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012098
