UMIN-CTR Clinical Trial

Public title

Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Registry 2

Acronym

RESCUE-Japan Registry 2

Scientific Title

Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Registry 2

Scientific Title:Acronym

RESCUE-Japan Registry 2

Region

Japan

Condition

Acute cerebral large vessel occlusion admitted within 24 hours after onset.

Classification by specialty

Medicine in general	Cardiology	Neurology
Radiology	Neurosurgery	Emergency medicine
Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to clarify treatment status and clinical results of acute cerebral ischemia after approval of clot retriever in Japan, and also to obtain a basis for comparative studies.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

modified Rankin Scale at 90 days (+/- 10 days) after onset

Key secondary outcomes

(1)Death within 90 days (+/- 10 day) after the onset
(2)The rate of mRS score 0-2 of each affected artery
(3)Symptomatic intracranial hemorrhage within 72 hours (+/- 8 hours) after onset.
(4)The difference of NIHSS score between pre-treatment and at 72 hours (+/- 8 hours) after onset.
(5)Other adverse events

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

100

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Patients admitted from Oct. 1st 2014 to Sep. 30th 2016
2)Patients who were 20 years or older admitted within 24 hours after onset
(3)The patients with large vessel occlusion (ICA, MCA, VA, BA, PCA).
4)Patients who did not mucth the criteria of RESCUE-Japan RCT.

Key exclusion criteria

Patients who are considered inappropriate to participate in the study are excluded.

Target sample size

1000

Name of lead principal investigator

1st name
Middle name
Last name	Shinichi Yoshimura , Nobuyuki Sakai

Organization

Hyogo College of Medicine

Division name

Department of Neurosurgery

Zip code

Address

1-1 Mukogawa, Nishinomiya, Hyogo, Japan

TEL

0798-45-6458

Email

rescue-j@hyo-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Kazutaka Uchida

Organization

Hyogo College of Medicine

Division name

Department of Neurosurgery

Zip code

Address

1-1 Mukogawa, Nishinomiya, Hyogo, Japan

TEL

0798-45-6458

Homepage URL

http://rescue-japan.jp/index.asp

Email

kuchida@hyo-med.ac.jp

Institute

Department of Neurosurgery
Hyogo College of Medicine

Institute

Department

Personal name

Organization

MHLW GRANTS

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Japan

Co-sponsor

Hyogo College of Medicine Clinical Research Support Center

Name of secondary funder(s)

The Japanese Society for NeuroEndovascular Therapy

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

伊勢赤十字病院、宇部興産中央病院、大垣徳洲会病院、大阪医科大学、大阪大学医学部附属病院、香川大学、川崎医科大学附属病院、金沢大学附属病院、北里大学、岐阜大学、九州医療センター、京都第一赤十字病院、近畿大学、倉敷中央病院、久留米大学病院、広南病院、神戸市立医療センター、神戸中央病院、小倉記念病院、国立循環器病研究センター、済生会富山病院
済生会長崎病院、埼玉医科大学国際医療センター、札幌医科大学、シミズ病院、順天堂大学順天堂医院、西湘病院、国立病院機構仙台医療センター、康生会武田病院、田主丸中央病院、多摩総合医療センター、徳島大学、虎ノ門病院、名古屋大学、名古屋第二赤十字病院、日本医科大学、函館新都市病院、函館脳神経外科病院、兵庫医科大学、兵庫県立姫路循環器病センター
弘前大学、広島大学、福井赤十字病院、福岡大学筑紫病院、マツダ病院、三重大学病院、都城市郡医師会病院、山口県立総合医療センター、山口大学、横浜新都市脳神経外科病院

Date of disclosure of the study information

2014

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2014

Year

09

Month

20

Day

Date of IRB

Anticipated trial start date

2014

Year

10

Month

01

Day

Last follow-up date

2017

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Primary endopoint
modified Rankin Scale at 90 days (+/- 10 days) after onset
Secondary endopoint
(1)Death within 90 days (+/- 10 day) after the onset
(2)The rate of mRS score 0-2 at each affected artery
(3)Symptomatic intracranial hemorrhage within 72 hours (+/- 8 hours) after onset.
(4)The difference of NIHSS score between pre-treatment and at 72 hours (+/- 8 hours) after onset.
(5)Other adverse events

Registered date

2014

Year

09

Month

29

Day

Last modified on

2018

Year

06

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017764