UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035438 |
|---|---|
| Receipt number | R000040374 |
| Scientific Title | Flowdiverter Therapy for Intracranial Aneurysm Registry in JAPAN |
| Date of disclosure of the study information | 2019/01/10 |
| Last modified on | 2019/01/04 12:42:20 |
* 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
Flowdiverter Therapy for Intracranial Aneurysm Registry in JAPAN
Acronym
Flower JAPAN
Scientific Title
Flowdiverter Therapy for Intracranial Aneurysm Registry in JAPAN
Scientific Title:Acronym
Flower JAPAN
Region
| Japan |
Condition
Condition
Cerebral aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of flow diverter treatment for cerebral aneurysms
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
curative occlusion of target aneurysm without any major adverse event
Key secondary outcomes
1. any death within 30days after procedure
2. any stroke within 30days after procedure
3. aneurysm rupture within 1 year after procedure
4. pretreatment within 1 year after procedure
5. disease or procedure related death within 1 year after procedure
6. disease or procedure related stroke within 1 years after procedure
7. disease or procedure related hemorrhagic event within 1 year after procedure
8. curative occlusion of target aneurysm 1 (3) year after procedure
9 retreatment of target aneurysm 1 (3) year after procedure
10 occlusion or stenosis of target artery
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 cerebral aneurysm
2 treated with Pipeline Flex
Key exclusion criteria
no limitation
Target sample size
1000
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
Center for Clinical Research and Innovation, Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
supported by post market surveillance committee of Japanese Society of Neuoendovascular Therapy
Management information
Registered date
| 2019 | Year | 01 | Month | 04 | Day |
Last modified on
| 2019 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040374
