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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040681
Receipt No. R000046431
Scientific Title Multi center registry of flow diverter treatment for intracranial aneurysms using FRED, initial experience in Japan
Date of disclosure of the study information 2020/06/10
Last modified on 2020/06/07

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Basic information
Public title Multi center registry of flow diverter treatment for intracranial aneurysms using FRED, initial experience in Japan
Acronym Post market surveillance of FRED
Scientific Title Multi center registry of flow diverter treatment for intracranial aneurysms using FRED, initial experience in Japan
Scientific Title:Acronym FRED PMS
Region
Japan

Condition
Condition intracranial aneurysm
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate safety and efficacy of initial experience of flow diverter treatment for intracranial aneurysm using FRED in Japan
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes stroke and death within 30 days after treatment
Key secondary outcomes 1. complete occlusion at 1 year after treatment
2. symptomatic stroke within 1 year after treatment
3, neurological death within 1 year after treatment
4. complete occluuion at 3 year after treatment
5. rupture of target aneurysm
6. re-treatment of target aneurysm
7. change in modified Rankin Scale
8. Severe adverse event within 1 year related to device
9. device failure

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 intracranial aneurysm
2 treated using FRED
Key exclusion criteria reject for registration by patient or family
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Nobuyuki
Middle name
Last name Sakai
Organization Kobe City Medical Center General Hospital
Division name Neurosurgery
Zip code 650-0047
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 Nobuyuki
Middle name
Last name Sakai
Organization Kobe City Medical Center General Hospital
Division name Neurosurgery
Zip code 650-0047
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 Japanese Society of Neuoendovascular Therapy
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kobe City Medical Center General Hospital
Address 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
Tel 078-302-4321
Email rinken@kcho.jp

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 広南病院(宮城県)、筑波大学(茨城県)、順天堂大学(東京都)、愛知医科大学(愛知県)、京都大学(京都府)、国立循環器病センター(大阪府)、大阪医療センター(大阪府)、兵庫医科大学(兵庫県)、神戸市立医療センター中央市民病院(兵庫県)、岡山大学(岡山県)、福岡大学筑紫病院(福岡県)

Other administrative information
Date of disclosure of the study information
2020 Year 06 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
2020 Year 06 Month 07 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective registry of initial experience of flow diverter treatment using FRED in Japan

Management information
Registered date
2020 Year 06 Month 07 Day
Last modified on
2020 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046431

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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