UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013143
Receipt number R000015307
Scientific Title Trans-arterial embolization of dural arteriovenous fistula using ONYX liquid embolic system. multi-center, prospective registry trial
Date of disclosure of the study information 2014/02/12
Last modified on 2014/02/12 15:56:36

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Basic information

Public title

Trans-arterial embolization of dural arteriovenous fistula using ONYX liquid embolic system. multi-center, prospective registry trial

Acronym

ONYX TAE for dAVF

Scientific Title

Trans-arterial embolization of dural arteriovenous fistula using ONYX liquid embolic system. multi-center, prospective registry trial

Scientific Title:Acronym

ONYX TAE for dAVF

Region

Japan


Condition

Condition

dural arteriovenous fistula

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm safety and efficacy of trans-arterial embolization of dural arteriovenous fistula using ONYX liquid embolic system

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

curative occlusion of dural arteriovenous fistula at 6 month after embolization

Key secondary outcomes

1. recanalization of target lesion at 6 months after embolization
2. repeat embolization for recanalization of target lesion at 6 months after embolization
3. stroke due to recanalization of target lesion at 6 months after embolization
4. any cause of death within 6 month after embolization
5. any cause of stroke at 6 month after embolization
6. neurological deterioration at 6 month after embolization
7. modified Rankin Scale at 6 month after embolization


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Trans-arterial embolization of dural arteriovenous fistula using ONYX liquid embolic system

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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1. modified Rankin Scale 4 or less
2. primary or recurrence of dural arteriovenous fistula
3. difficult to cure by trensvenous embolization
4. exist feeding artery suitable for ONYX embolization
5. accept documented connect form

Key exclusion criteria

1. not indicated for intravenous heparin
2. difficult to follow-up for 6 months
3. allergy for iodine contrast
4. allergy for tantalum

Target sample size

22


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 or person

Institute

Kobe City Medical Center General Hospital

Institute

Department

Personal name



Funding Source

Organization

MHLW Grant for medical study

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Center for clinical trial, Japan Medical Association

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

神戸市立医療センター中央市民病院、富山大学、岡山大学


Other administrative information

Date of disclosure of the study information

2014 Year 02 Month 12 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

Open public recruiting

Date of protocol fixation

2013 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 15 Day

Last follow-up date

2016 Year 06 Month 30 Day

Date of closure to data entry

2016 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 02 Month 12 Day

Last modified on

2014 Year 02 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015307


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name