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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035438
Receipt No. 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

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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
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 Center for Clinical Research and Innovation, Kobe City Medical Center General Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040374

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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