UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Randomized Controlled Trial
Title of the study (Brief title)	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	Shinichi Yoshimura , Nobuyuki Sakai
Organization	Hyogo College of Medicine
Division name	Department of Neurosurgery
Address	1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL	0798-45-6458
Email	rescue-j@hyo-med.ac.jp

Public contact
Name of contact person	Kazutaka Uchida
Organization	Hyogo College of Medicine
Division name	Department of Neurosurgery
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
Institute	Department of Neurosurgery Hyogo College of Medicine
Institute
Department

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

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 09 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017762