UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014379
Receipt number 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 2021/09/07 15:18:50

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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 Susumu
Middle name
Last name Miyamoto

Organization

Kyoto University, Graduate School of Medicine

Division name

Department of Neurosurgery

Zip code

606-8507

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 Akira
Middle name
Last name Ishii

Organization

Kyoto University, Graduate School of Medicine

Division name

Department of Neurosurgery

Zip code

606-8507

Address

Kawahara-cho 54, Syogoin, Sakyo-ku, Kyoto-city

TEL

075-751-3459

Homepage URL


Email

dural@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



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

Kyoto University Graduate School and Faculty of Medicine, Ethics committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.ac.jp


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

NA

Publication of results

Published


Result

URL related to results and publications

NA

Number of participants that the trial has enrolled

110

Results

No patient had conversion to higher type of Borden classification or intracranial hemorrhage during the follow-up. Five patients showed spontaneous improvement of neurological symptoms (5/28, 17.9%), and 5 patients showed a spontaneous decrease of shunt flow on imaging during follow-up (17.9%). The stenosis or occlusion of the draining sinuses at initial angiography was significantly associated with the shunt flow reduction during the follow-up (p=0.02).

Results date posted

2021 Year 06 Month 30 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

From April 2013 to March 2016, consecutive patients with DAVF were screened at 13 study institutions. 110 patients with intracranial DAVF were screened and 28 patients with Borden type I DAVF were prospectively followed.

Participant flow

We collected data on baseline characteristics, clinical symptoms, angiography, and neuroimaging. Patients with Borden type I DAVF received conservative care while palliative intervention was considered when the neurological symptoms were intolerable, and were followed at 6, 12, 24, and 36 months after inclusion.

Adverse events

None due to the observational nature of the present study.

Outcome measures

deterioration of the neurological symptoms, MRI at 6, 12, 24, and 36 months after enrollment.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2013 Year 04 Month 01 Day

Date of IRB

2013 Year 03 Month 25 Day

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

2021 Year 09 Month 07 Day



Link to view the page

Value
https://center6.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