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
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
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
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
