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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024727
Receipt No. R000028451
Scientific Title Contrast enhansed ultrasound in evalution of in-stent prtrusion after carotid stenting.
Date of disclosure of the study information 2016/11/06
Last modified on 2017/09/13

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Basic information
Public title Contrast enhansed ultrasound in evalution of in-stent prtrusion after carotid stenting.
Acronym Contrast enhansed ultrasound in evalution of in-stent prtrusion after carotid stenting.
Scientific Title Contrast enhansed ultrasound in evalution of in-stent prtrusion after carotid stenting.
Scientific Title:Acronym Contrast enhansed ultrasound in evalution of in-stent prtrusion after carotid stenting.
Region
Japan

Condition
Condition Stroke,Carotid stenosis
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evalute in-stent protrusion after carotid stenting
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes in-stent protrusion after carotid stenting
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 contrast enhanced ultrasound using sonazoid.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria after carotid stenting
Key exclusion criteria Not get consent
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jyunichi Uemura
Organization Kawasaki Medical School
Division name Department of Stroke Medicine
Zip code
Address Kurashiki, Okayama 701-0192, Japan
TEL 086-462-1111
Email uemuratrail@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jyunichi Uemura
Organization Kawasaki Medical School
Division name Department of Stroke Medicine
Zip code
Address Kurashiki, Okayama 701-0192, Japan
TEL 086-462-1111
Homepage URL
Email uemuratrail@yahoo.co.jp

Sponsor
Institute Department of Stroke Medicine,Kawasaki Medical School
Institute
Department

Funding Source
Organization Department of Stroke Medicine,Kawasaki Medical School
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
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 11 Month 06 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 Completed
Date of protocol fixation
2015 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 30 Day
Last follow-up date
2017 Year 07 Month 29 Day
Date of closure to data entry
2017 Year 07 Month 29 Day
Date trial data considered complete
2017 Year 07 Month 29 Day
Date analysis concluded
2017 Year 07 Month 29 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 06 Day
Last modified on
2017 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028451

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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