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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014379
Receipt No. R000015833
Scientific Title Multicenter prospective registry of dural arteriovenous fistula without retrograde leptomeningeal venous drainage
Date of disclosure of the study information 2014/07/01
Last modified on 2018/07/02

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Basic information
Public title Multicenter prospective registry of dural arteriovenous fistula without retrograde leptomeningeal venous drainage
Acronym Multicenter prospective registry of dural arteriovenous fistula without retrograde leptomeningeal venous drainage
Scientific Title Multicenter prospective registry of dural arteriovenous fistula without retrograde leptomeningeal venous drainage
Scientific Title:Acronym Multicenter prospective registry of dural arteriovenous fistula without retrograde leptomeningeal venous drainage
Region
Japan

Condition
Condition dural arteriovenous fistula
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To ellcidate the natural course of dural arteriovenous fistula with no retrograde leptomeningeal venous drainage
Basic objectives2 Others
Basic objectives -Others natural history
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) death
2) any stroke
Key secondary outcomes 1) any treatment intervention
2) change of Borden classification
3) any new finding on brain MRI

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) diagnosed as dural arteriovenous fistula
2) confirmed by digital subtraction angiography (DSA)
3) eligible for follow-up
Key exclusion criteria none
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Miyamoto
Organization Kyoto University, Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
Address Kawahara-cho 54, Syogoin, Sakyo-ku, Kyoto-city
TEL 075-751-3459
Email miy@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Ishii
Organization Kyoto University, Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
Address Kawahara-cho 54, Syogoin, Sakyo-ku, Kyoto-city
TEL 075-751-3459
Homepage URL
Email dural@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Japanese Society for Neuroendovascular Therapy
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
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 京都大学(京都府)、城山病院(大阪府)、神戸市立医療センター中央市民病院(兵庫県)、神鋼病院(兵庫県)、横浜新都市脳神経外科病院(神奈川県)、小倉記念病院(福岡県)、松下記念病院(大阪府)、赤穂市民病院(兵庫県)、滋賀県立成人病センター(滋賀県)、倉敷中央病院(岡山県)、京都医療センター(京都府)、康生会武田病院(京都府)、高松赤十字病院(香川県)、高知医療センター(高知県)、福井赤十字病院(福井県)、国立循環器病研究センター(大阪府)、市立長浜病院(滋賀県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 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 No longer recruiting
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Primary outcome
any death, any stroke

Secondary outcome
1) Surgical intervention
2) change of Borden type
3) new findings on brain MRI

Management information
Registered date
2014 Year 06 Month 26 Day
Last modified on
2018 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015833

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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