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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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