UMIN-CTR Clinical Trial

Basic information
Public title	Blood flow measurements before and after carotid artery stenting
Acronym	Blood flow measurements before and after carotid artery stenting
Scientific Title	Blood flow measurements before and after carotid artery stenting
Scientific Title:Acronym	Blood flow measurements before and after carotid artery stenting
Region	Japan

Condition
Condition	carotid artery stenosis
Classification by specialty	Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To measure blood flow volume rates of the bilateral internal carotid arteries and the basilar artery before and after carotid artery stenting and to elucidate time trend of total cerebral blood flow rate.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood flow volume rates at three months after carotid artery stenting
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient planned to undergo carotid artery stenting
Key exclusion criteria	Patient who refuses
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hisashi Tanaka
Organization	Osaka University Graduate School of Medicine
Division name	Radiology
Zip code
Address	Yamadaoka 2-2, Suita, Osaka 565-0871, Japan
TEL	+81-6-6879-3434
Email	tanaka@radiol.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hisashi Tanaka
Organization	Osaka University, Graduate school of medicine
Division name	Radiology
Zip code
Address	Yamadaoka 2-2, Suita, Osaka 565-0871, Japan
TEL	+81-6-6879-3434
Homepage URL
Email	tanaka@radiol.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University, Graduate school of medicine, Department of Radiology
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2016 Year 02 Month 28 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	11
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2018 Year 04 Month 11 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 11 Day
Date of IRB	2014 Year 06 Month 12 Day
Anticipated trial start date	2014 Year 06 Month 12 Day
Last follow-up date	2020 Year 09 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 09 Month 02 Day

Other
Other related information	To measure blood flow rate before and after carotid artery stenting.

Management information
Registered date	2016 Year 02 Month 18 Day
Last modified on	2020 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024328