UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Flowdiverter Therapy for Intracranial Aneurysm Registry in JAPAN
Title of the study (Brief title)	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	Nobuyuki Sakai
Organization	Kobe City Medical Center General Hospital
Division name	Neurosurgery
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	Nobuyuki Sakai
Organization	Kobe City Medical Center General Hospital
Division name	Neurosurgery
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 01 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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