UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research aimed at shortening time to the start of endovascular therapy for large vessel occlusion acute ischemic stroke
Acronym	startEVT
Scientific Title	Clinical research aimed at shortening time to the start of endovascular therapy for large vessel occlusion acute ischemic stroke
Scientific Title:Acronym	startEVT
Region	Japan

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

Objectives
Narrative objectives1	To analyze the time to the start of endovascular therapy for anterior circulation cerebral large vessel occlusion within 24 hours after onset. Identify factors that are effective in shortening time to treatment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time from arrival to start endovascular therapy
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	20 years-old <=
Age-upper limit	110 years-old >
Gender	Male and Female
Key inclusion criteria	acute cerebral ischemic stroke(anterior circulation(ICA,M1,M2) start endovascular therapy within 24hours after onset
Key exclusion criteria	Acute aortic dissection Pregnant or possibility of pregnancy Cases where imaging tests cannot be performed due to contrast media allergy or severe renal dysfunction Cases transported after examination and treatment from another hospital expression of withdrawal of consent Cases where participation in this study is deemed inappropriate
Target sample size	850

Research contact person
Name of lead principal investigator	1st name Kawakami Middle name Last name Osamu
Organization	National hospital organization kyoto medical center
Division name	Department of Neurosurgery
Zip code	6128555
Address	Kyoto-city fushimi-ku fukakusa mukaihata-cho 1-1
TEL	0756419161
Email	kawakami-nsu@umin.ac.jp

Public contact
Name of contact person	1st name Kawakami Middle name Last name Osamu
Organization	National hospital organization kyoto medical center
Division name	Department of Neurosurgery
Zip code	6128555
Address	Kyoto-city fushimi-ku fukakusa mukaihata-cho 1-1
TEL	0756419161
Homepage URL
Email	kawakami-nsu@umin.ac.jp

Sponsor
Institute	National hospital organization kyoto medical center
Institute
Department

Funding Source
Organization	National hospital organization
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National hospital organization
Address	Tokyo-to meguro-ku higashigaoka 2-5-21
Tel	03-5712-5050
Email	700-kenkyu@mail.hosp.go.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

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 18 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	Enrolling by invitation
Date of protocol fixation	2019 Year 11 Month 12 Day
Date of IRB	2019 Year 11 Month 12 Day
Anticipated trial start date	2019 Year 12 Month 18 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Time from arrival to start endovascular therapy mRS(90 days after onset)

Management information
Registered date	2019 Year 12 Month 18 Day
Last modified on	2019 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044373