UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015272
Receipt number R000017762
Scientific Title Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Randomized Controlled Trial
Date of disclosure of the study information 2014/10/01
Last modified on 2018/06/10 19:10:04

* 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

Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Randomized Controlled Trial

Acronym

RESCUE-Japan RCT

Scientific Title

Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Randomized Controlled Trial

Scientific Title:Acronym

RESCUE-Japan RCT

Region

Japan


Condition

Condition

Acute ischemic stroke patients due to IC and M1 proximal occlusion who received intravenous rt-PA therapy within 4.5 hours after onset

Classification by specialty

Medicine in general Cardiology Neurology
Radiology Neurosurgery Emergency medicine
Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to clarify the efficacy of the endovascular treatment for acute ischemic stroke patients with large vessel occlusion and are not respond to intravenous recombinant tissue plasminogen activator (rt-PA) therapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Shift analysis of modified Rankin Scale at 90 days after onset

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Group with additional endovascular treatment

Interventions/Control_2

Group without additional endovascular treatment

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Acute ischemic stroke patients who were treated with intravenous rt-PA therapy within 4.5 hours from onset and have persistent occlusion of IC and M1 proximal portion* confirmed by cerebral angiography.
*: M1 proximal portion means the segment of MCA within 5mm from the internal carotid bifurcation.
2) Patients who can receive endovascular treatment within 8 hours after the onset.
3) Patients whose DWI-ASPECTS is 5 points or more, or CT-ASPECT is 6 points or more just before cerebral angiography.
4) Patients whose NIHSS is between 8 and 29 points.
5) Patients who are between 20 and 85 years.
6) Gender does not matter.
7) Consent of this study participants must be obtained from patients or legal representative in writing.

Key exclusion criteria

1)Patients whose neurological symptoms improved and NIHSS is eight points or less after intravenous rt-PA therapy.
2)Patients whose mRS is 3 points or more before the onset.
3)Patients with past history of lumbar puncture or arterial puncture that were difficult of hemostasis.
4)Patients with intracranial tumor
5)Patients with hypersensitivity to contrast agent.
6)Patients with serious renal disease.
7)Patients with malignant tumor.
8)Patients with pregnancy or suspect of pregnancy, or during lactation.
9)Patients with findings of acute myocardial infarction or pericarditis after myocardial infarction.
10)Patients who cannot be followed for 3 months.
11)Patients with past history of cerebral aneurysm, cerebral arteriovenous malformation, cerebral venous thrombosis, or moyamoya disease.
12)Patients with other occlusions besides ICA or M1 proximal portion.
13)Patients with arterial dissection complicating endovascular treatment.
14)Patients with tortuous arteries that disturb navigation of the device to the target vessel.
15)Patients considered inappropriate to participate in the study.

Target sample size

200


Research contact person

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


Public contact

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


Sponsor or person

Institute

Department of Neurosurgery
Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

Health, Labor and Welfare Research Institute expenses

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Hyogo College of Medicine Clinical Research Support Center

Name of secondary funder(s)

The Japanese Society for NeuroEndovascular Therapy


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

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


Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 01 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

Terminated

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


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 09 Month 28 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=R000017762


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name