UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034344 |
|---|---|
| Receipt number | R000039150 |
| Scientific Title | Muti-center registry of trans-arterial embolization using Onyx for dural arterio-venous fistula |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2018/10/01 14:32:21 |
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Basic information
Public title
Muti-center registry of trans-arterial embolization using Onyx for dural arterio-venous fistula
Acronym
Onyx dAVF TAE Registry
Scientific Title
Muti-center registry of trans-arterial embolization using Onyx for dural arterio-venous fistula
Scientific Title:Acronym
Onyx dAVF TAE Registry
Region
| Japan |
Condition
Condition
dural arterio-venous fistula
Classification by specialty
| Radiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of trans-arterial embolization using Onyx for dural arterio-venous fistula
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
technical success of embolization without any death and procedure related stroke within 30 days
Key secondary outcomes
1) curative occlusion by DSA at 6 months follow-up
2) recanalization at 6 months
3) retreatment for recanalization within 6 months
4) any death within 6 months
5) any related stroke within 6 months
6) neurological deterioration at 6 months
7) modified Rankin Score at 6 months
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) dural arterio-venous fistula
2) trans-arterial embolization using Onyx
Key exclusion criteria
1) no limtation
Target sample size
500
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
n.sakai@siren.ocn.ne.jp
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
n.sakai@siren.ocn.ne.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe City Medical Center General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Japanese Society of Neuoendovascular Therapy
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
仙台医療センター（宮城県）、広南病院（宮城県）、筑波大学（茨城県）、順天堂大学（東京都）、昭和大学藤が丘病院（神奈川県）、新潟大学（新潟県）、富山大学（富山県）、名古屋大学（愛知県）、愛知医科大学（愛知県）京都大学（京都府）、国立循環器病研究センター（大阪府）、大阪医療センター（大阪府）、兵庫医科大学（兵庫県）、神戸市立医療センター中央市民病院（兵庫県）、岡山大学（岡山県）、九州大学（福岡県）、福岡大学（福岡県）、等
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 01 | 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
| 2018 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study of trans-arterial embolization using Onyx for dural AVF after approval in Japan. Japanese Society of Neuoendovascular Therapy contol this study.
Management information
Registered date
| 2018 | Year | 10 | Month | 01 | Day |
Last modified on
| 2018 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039150
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
