UMIN-CTR Clinical Trial

Basic information
Public title	MHLW registry of mechanical thrombectomy for acute ischemic stroke
Acronym	MHLW MT registry
Scientific Title	MHLW registry of mechanical thrombectomy for acute ischemic stroke
Scientific Title:Acronym	MHLW MT registry
Region	Japan

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

Objectives
Narrative objectives1	To investigate changes in stroke care after stroke center certification, safety and efficacy of mechanical thrombectomy for acute ischemic stroke
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rodified Rankin Score 0-2 at 90days after onset
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patient, treated with mechanical thrombectomy
Key exclusion criteria	no limitation
Target sample size	10000

Research contact person
Name of lead principal investigator	1st name Nobuyuki Middle name Last name Sakai
Organization	Kobe City Medical Center General Hospital
Division name	Neurosurgery
Zip code	650-0047
Address	2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL	078+302-4321
Email	n.sakai@siren.ocn.ne.jp

Public contact
Name of contact person	1st name Chiaki Middle name Last name Sakai
Organization	Kobe City Medical Center General Hospital
Division name	Center for Clinical Research and Innovation
Zip code	650-0047
Address	2-2 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL	078-302-4321
Homepage URL	http://sc-res.umin.jp/
Email	chiakimk@cronos.ocn.ne.jp

Sponsor
Institute	Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Kobe City Medical Center General Hospital
Address	2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
Tel	078-302-4321
Email	rinken@kcho.jp

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	岩手医科大学、東北大学、筑波大学、日本医科大学、富山大学、岐阜大学、京都大学、国立循環器病研究センター、兵庫医科大学、神戸市立医療センター中央市民病院、川﨑医科大学、九州医療センター、他

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 26 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	Open public recruiting
Date of protocol fixation	2020 Year 12 Month 09 Day
Date of IRB	2020 Year 12 Month 10 Day
Anticipated trial start date	2021 Year 01 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Registration of mechanical thrombectomy, transfer or mother ship emergency care for acute ischemic stroke in 2019 to 2021.

Management information
Registered date	2020 Year 12 Month 26 Day
Last modified on	2021 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048925