UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013143
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Kobe City Medical Center General Hospital
Institute
Department

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
URL(English) https://upload.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


Contact us.