UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endovascular recanalization therapy for acute ischemic stroke
Title of the study (Brief title)	Endovascular recanalization therapy for acute ischemic stroke
Region	Japan

Condition
Condition	acute ischemic stroke
Classification by specialty	Neurology Radiology Neurosurgery Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of the endovascular recanalization treatment for acute ischemic stroke
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recanalization rate
Key secondary outcomes	Clinical outcome Rate of hemorrhagic infarction Procedure related complications

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
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	(1)Patients without neurological improvement, and NIHSS>8points, no hemorrhage on CTscan after the completion of IV tPA (2)Patients who are ineligible for IV tPA and meet all of the following criteria: age>18, NIHSS>8, < 6hours of stroke symptom onset,no or only subtle early ischemic signs on CTscan, mismatch of MRI-DWI and clinical symptoms.
Key exclusion criteria	(1)current pregnancy, (2) serum glucose>50mg/dl, (3)sustained systolic blood pressure>185mmHg despite treatment, (4)platelet count<30000, (5) INR>3.0, (6) history of severe allergy or severe renal failure which restrict the use of contrast media, (7) CT revealing significant mass effect with midline shift or hemorrhage, (8)informed consent is not obtained.
Target sample size	30

Research contact person
Name of lead principal investigator	Satoshi Ushikoshi
Organization	Hokkaido Medical Center
Division name	Department of Neurosurgery
Address	5-7, Yamanote, Sapporo, Japan
TEL	011-611-8111
Email

Public contact
Name of contact person	Satoshi Ushikoshi
Organization	Hokkaido Medical Center
Division name	Department of Neurosurgery
Address	5-7, Yamanote, Sapporo, Japan
TEL	011-611-8111
Homepage URL
Email

Sponsor
Institute	Hokkaido Medical Center
Institute
Department

Funding Source
Organization	None
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	北海道医療センター（北海道）

Other administrative information
Date of disclosure of the study information	2010 Year 05 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 04 Month 28 Day
Anticipated trial start date	2010 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2014 Year 03 Month 31 Day
Date analysis concluded

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

Management information
Registered date	2010 Year 05 Month 19 Day
Last modified on	2016 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004393