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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014483
Receipt No. R000016850
Scientific Title Prospective Registry of Solitaire FR Endovascular Recanalization Treatment for Acute Stroke - Post Market Surveillance in Japan
Date of disclosure of the study information 2014/07/07
Last modified on 2014/07/06

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Basic information
Public title Prospective Registry of Solitaire FR Endovascular Recanalization Treatment for Acute Stroke - Post Market Surveillance in Japan
Acronym Study of safety And efficacy on Post MarKeting SUrveillance of Solitaire FR for cerebral Acute Stroke
(SAKURA)
Scientific Title Prospective Registry of Solitaire FR Endovascular Recanalization Treatment for Acute Stroke - Post Market Surveillance in Japan
Scientific Title:Acronym Study of safety And efficacy on Post MarKeting SUrveillance of Solitaire FR for cerebral Acute Stroke
(SAKURA)
Region
Japan

Condition
Condition acute stroke
Classification by specialty
Neurology Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate postmarket surveillance of Splitaire FR thrombectomy for acute stroke.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes modified Rankin Scale 0-2 90days after treatment
Key secondary outcomes 1. recanalization of target artery
2. mRS 0-1 90days after treatment
3. change in NIHSS
4. relation between recanalization and prognosis
5. symptomatic intracranial hemorrhage within 24 hours
6. death within 90days
7. adverse event

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is 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 Slitaire FR thrombectomy for acute stroke
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 Patient who received mechanical thrmobectomy using Solitaire FR
2 Patient who registrate to post market surveillance of Solitaire FR thrombectomy
Key exclusion criteria not determined
Target sample size 240

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 0783024321
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 0783024321
Homepage URL
Email n.sakai@siren.ocn.ne.jp

Sponsor
Institute Society of device and technique for neuroendovascular therapy
Institute
Department

Funding Source
Organization Society of device and technique for neuroendovascular therap
Organization
Division
Category of Funding Organization Self funding
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 神戸市立医療センター中央市民病院、仙台医療センター、広南病院、福井赤十字病院、虎の門病院、北里大学、伊勢赤十字病院、京都第一赤十字病院、国立循環器病研究センター、兵庫医科大学、大田記念病院、マツダ病院、岡山大学、久留米大学

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 07 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
2014 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 15 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 06 Month 30 Day
Date trial data considered complete
2016 Year 09 Month 30 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 06 Day
Last modified on
2014 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016850

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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