UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014483 |
|---|---|
| Receipt number | 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 09:48:48 |
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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
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
n.sakai@siren.ocn.ne.jp
Sponsor or person
Institute
Society of device and technique for neuroendovascular therapy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016850
