UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006748 |
|---|---|
| Receipt number | R000007977 |
| Scientific Title | Efficacy of Hydrocoil on endovascular treatment for intracranial aneurysms; Multi-center, prospective, randomized, open-label blind-endpoint trial |
| Date of disclosure of the study information | 2011/12/21 |
| Last modified on | 2019/10/08 17:12:37 |
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Basic information
Public title
Efficacy of Hydrocoil on endovascular treatment for intracranial aneurysms; Multi-center, prospective, randomized, open-label blind-endpoint trial
Acronym
HYBRID (HYdrocoil versus Bare platinum coil in Recanalization Imaging Data) study
Scientific Title
Efficacy of Hydrocoil on endovascular treatment for intracranial aneurysms; Multi-center, prospective, randomized, open-label blind-endpoint trial
Scientific Title:Acronym
HYBRID (HYdrocoil versus Bare platinum coil in Recanalization Imaging Data) study
Region
| Japan |
Condition
Condition
Intracranial anerysm
Classification by specialty
| Radiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare Hydrocoil and bare platinum coil for recanalization after endovascular treatment of intracranial aneurysms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
recanalization within 1 year after embolization
Key secondary outcomes
1. aneurysmal rupture within 1 year after embolization
2. any event within 30 days after embolization
3. recanalization within 6 months after embolization
4. aneurysmal retreatment within 1 year after embolization
5. aneurysmal rupture and any death within 1 year after embolization
6. any stroke within 1 year after embolization
7. any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization
8. change in aneurysmal occlusion
9. any comlicaion within 1 year after embolization
10. %length of Hydrocoil, maximum diameter of aneurysm, volume embolization ratio
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Hydrocoil
Interventions/Control_2
Bare Platinum Coil
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 intracranial aneurysm
2. endovascular treatment scheduled within 60days after consent
3. 20-79 years old
4. unruptured, chronic SAH or acurte SAH Grade 1-III
5. 7-20mm in size
6. 1 year follow up possibel
7. independent (mRS 0-2)
8. document consent
Key exclusion criteria
1. previous endovascular treated
2. additional aneurysm scheduled of endovascular treatment
3. pregnant
4. ineligible for study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Sakai |
Organization
Kobe City Medical Center General Hospital
Division name
Neurosurgery
Zip code
650-0047
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL
078-302-4321
n.sakai@siren.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Sakai |
Organization
Kobe City Medical Center general Hospital
Division name
Neurosurgery
Zip code
650-0047
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL
078-302-4321
Homepage URL
n.sakai@siren.ocn.ne.jp
Sponsor or person
Institute
Transitional Research Informatics Center
Institute
Department
Personal name
Funding Source
Organization
Transitional Research Informatics Center
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe City Medical Center General Hospital
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
Tel
078-302-4321
rinken@kcho.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01516658
Org. issuing International ID_1
ClinicalTrials.gov
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）、仙台医療センター（宮城県）、広南病院（宮城県）、獨協医科大学越谷病院（埼玉県）、千葉県救命救急センター（千葉県）、千葉大学（千葉県）、虎の門病院（東京都）、東京医科歯科大学（東京都）、新潟大学（新潟県）、富山大学（富山県）、信州大学（長野県）、名古屋大学（愛知県）、岐阜大学（岐阜県）、京都大学（京都府）、大阪大学（大阪府）、国立循環器病研究センター（大阪府）、和歌山労災病院（和歌山県）、岡山大学（岡山県）、山口大学（山口県）、香川大学（香川県）、徳島大学（徳島県）、小倉記念病院（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
| 2011 | Year | 12 | Month | 21 | 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
437
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
not yet reported
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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2011 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 20 | Day |
Last modified on
| 2019 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007977
