UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the endovascular treatment for the main artery occlusion after intravenous t-PA treatment
Title of the study (Brief title)	A study of the endovascular treatment after intravenous t-PA treatment
Region	Japan

Condition
Condition	Cerebral infarction within onset three hours
Classification by specialty	Cardiology Neurology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to elucidate whether recanalization therapy by the endovascular treatment is useful in a patients with cerebral infarcition for hyper-acute phase.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Number of patients that modified Rankin's scale onset three months later is 0 to 2.
Key secondary outcomes	Symptomatic intracranial hemorrhage within onset of 24 hours Death within onset three months Presence of recanalization just after the endovascular treatment NIHSS score: after treatment of 24 hours, 7days, and discharge Other adverse effect

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	endovascular treatment
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A case with main cerebral artery (ICA, MCA, VA, BA) occlusion who has administered iv-tPA within three hours onset
Key exclusion criteria	The patient having contrast media allergy contraindication for iv-tPA treatment
Target sample size	15

Research contact person
Name of lead principal investigator	Masao Watanabe
Organization	Kawasaki Medical School
Division name	Department of stroke medicine
Address	577 Matsushima, Kurashiki city, Okayama, Japan
TEL	086-462-1111
Email	masao-w@par.odn.ne.jp

Public contact
Name of contact person	Masao Watanabe
Organization	Kawasaki Medical School
Division name	Department of stroke medicine
Address	577 Matsushima, Kurashiki city, Okayama, Japan
TEL	086-462-1111
Homepage URL
Email	masao-w@par.odn.ne.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Kawasaki Medical School
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	川崎医科大学附属病院

Other administrative information
Date of disclosure of the study information	2011 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 01 Month 04 Day
Anticipated trial start date	2011 Year 02 Month 01 Day
Last follow-up date	2011 Year 02 Month 16 Day
Date of closure to data entry	2011 Year 02 Month 16 Day
Date trial data considered complete	2011 Year 02 Month 16 Day
Date analysis concluded	2011 Year 02 Month 16 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 01 Month 12 Day
Last modified on	2018 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005661