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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034344
Receipt No. 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

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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
Email 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
Email n.sakai@siren.ocn.ne.jp

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039150

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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