UMIN-CTR Clinical Trial

Basic information
Public title	Effects of carotid endarterectomy (CEA) vs carotid artery stenting (CAS) on equilibrium function
Acronym	Effects of carotid endarterectomy (CEA) vs carotid artery stenting (CAS) on equilibrium function
Scientific Title	Effects of carotid endarterectomy (CEA) vs carotid artery stenting (CAS) on equilibrium function
Scientific Title:Acronym	Effects of carotid endarterectomy (CEA) vs carotid artery stenting (CAS) on equilibrium function
Region	Japan

Condition
Condition	Carotid artery stenosis
Classification by specialty	Neurology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of CEA and CAS on equilibrium function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in subjective symptoms and neurootolonical/neuroophthalmological test results
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	18 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with carotid artery stenosis requiring CEA or CAS
Key exclusion criteria	Patients who cannot be tested (such as dementia and paresis)
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Ken Middle name Last name Johkura
Organization	Yokohama Brain and Spine Center
Division name	Neurology and Stroke Center
Zip code	235-0012
Address	1-2-1 Takigashira, Isogo-ku, Yokohama, Japan
TEL	045-753-2500
Email	ke00-johkura@city.yokohama.jp

Public contact
Name of contact person	1st name Ken Middle name Last name Johkura
Organization	Yokohama Brain and Spine Center
Division name	Ethics Committee
Zip code	235-0012
Address	1-2-1 Takigashira, Isogo-ku, Yokohama, Japan
TEL	045-753-2500
Homepage URL
Email	ke00-johkura@city.yokohama.jp

Sponsor
Institute	Yokohama Brain and Spine Center
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics Committee, Yokohama Brain and Spine Center
Address	1-2-1 Takigashira, Isogo-ku, Yokohama, Japan
Tel	045-753-2500
Email	by-no-soumu@city.yokohama.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	2020 Year 05 Month 01 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	2019 Year 06 Month 01 Day
Date of IRB	2019 Year 07 Month 03 Day
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2023 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	NoneQuestionnaire, vestibulo-ocular reflex, vestibular evoked myogenic potential, Gravicoder, eye tracking test, Carotid untrasonography, SPECT, MRI

Management information
Registered date	2020 Year 04 Month 23 Day
Last modified on	2020 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045890

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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