UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040681
Receipt number 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 18:52:11

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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 or person

Institute

Kobe City Medical Center General Hospital

Institute

Department

Personal name



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

Value
https://center6.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