UMIN-CTR Clinical Trial

Public title

Randomized controlled trial of endovascular therapy for acute large vessel occlusion with large ischemic core

Acronym

RESCUE-Japan LIMIT

Scientific Title

Randomized controlled trial of endovascular therapy for acute large vessel occlusion with large ischemic core

Scientific Title:Acronym

RESCUE-Japan LIMIT

Region

Japan

Condition

Acute large vessel occlusion

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to investigate the efficacy of endovascular treatment for acute large vessel occlusion with large ischemic core (CT-ASPECT score 3-5 or DWI-ASPECT score 3-5).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase IV

Primary outcomes

modified Rankin Scale 0-3 at 90 days

Key secondary outcomes

1) modified Rankin Scale 0-2 at 90 days
2) modified Rankin Scale 0-1 at 90 days
3) Distribution of patients across the ordinal modified Rankin scale
4) NIHSS improvement 8 points or more at 48 hours

Safety outcome
1) Symptomatic intracranial hemorrhage within 48 hours
2) Intracranial hemorrhage within 48 hours
3) Death
4) Recurrence of cerebral infarction within 90 days
5) Decompressive craniectomy within 7 days

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Best medical treatment for cerebral infarction

Interventions/Control_2

Best medical treatment for cerebral infarction with 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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Acute cerebral infarction patient
2) Patients's age => 18
3) Patients with NIHSS => 6
4) Prestroke Modified Rankin Score 0-1
5) ICA or M1 Occlusion on CT angiography or MR angiography
6) ASPECTS 3-5 or DWI-ASPECTS 3-5
7) Randamization can be finished within 6 hours from last known well time, or 6 to 24 hours from last well known well time without positive lesion on MRI-FLAIR image.
8) Endovascular treatment can be initiatedwithin 60 minutes from randomization
9) Patient or Legally Authorized Representative has signed the Informed Consent form

Key exclusion criteria

1) Significant mass effect with midline shift
2) Known allergy to contrast agents
3) Evidence of acute intracranial hemorrhage
4) Pregnant
5) Clinical evidence of chronic occlusion
6) High risk of hemorrhage (platelet < 40,000/ul, APTT > 50 second or PT-INR > 3.0)
7) Participating in any other therapeutic investigational trial
8) Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Shinichi Yoshimura

Organization

Hyogo College of Medicine

Division name

Department of Neurosurgery

Zip code

Address

1-1 Mukogawa, Nishinomiya, Hyogo

TEL

0798-45-6455

Email

s-yoshi@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

TEL

0798-45-6458

Homepage URL

http://www.rescue-japan.jp/

Email

rescue-j@hyo-med.ac.jp

Institute

Department of Neurosurgery, Hyogo College of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

Date of disclosure of the study information

2019

Year

03

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

200

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

2018

Year

07

Month

30

Day

Date of IRB

2018

Year

10

Month

01

Day

Anticipated trial start date

2018

Year

10

Month

01

Day

Last follow-up date

2021

Year

12

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

10

Month

05

Day

Last modified on

2023

Year

06

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038184