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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003075
Receipt No. R000003732
Scientific Title Clinical study of stenting for supraaortic and intracranial arteries disease using coronary and biliary stent
Date of disclosure of the study information 2010/03/01
Last modified on 2011/02/17

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Basic information
Public title Clinical study of stenting for supraaortic and intracranial arteries disease using coronary and biliary stent
Acronym Stenting of supraaortic and intracranial arteries using coronary and biliary stent
Scientific Title Clinical study of stenting for supraaortic and intracranial arteries disease using coronary and biliary stent
Scientific Title:Acronym Stenting of supraaortic and intracranial arteries using coronary and biliary stent
Region
Japan

Condition
Condition Cervical and intracranial artery disease
Classification by specialty
Neurosurgery Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To know safety and usefulness of stenting for cervical and intracranial artery disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Neurological and radiological status just after treatment
2) modified Rankin Scale 3 months later
3) Hemorrhagic event within 24 hours after treatment
4) death
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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Endovascular treatment using stent
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
1 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria 1) Severe stenosis of cervical and intracranial artery (>70%)
2) Dissection of cervical and intracranial artery
3) Aneurysm of cervical and intracranial artery
4) Occlusion of cervical and intracranial artery
Key exclusion criteria 1) Unsuitable lesion for endovascular treatment
2) Prognosis less than 1 year
3) Contrast allergy
4) Contraindication of antithrobmotic therapy
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Yoshimura
Organization Graduate School of Medicine, Gifu University
Division name Department of Neurosurgery
Zip code
Address 1-1 Yanagido, Gifu city, Gifu, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medicine, Gifu University
Division name Department of Neurosurgery
Zip code
Address 1-1 Yanagido, Gifu city, Gifu, Japan
TEL +81-58-230-6271
Homepage URL
Email s-yoshi@gifu-u.ac.jp

Sponsor
Institute Department of Neurosurgery, Graduate School of Medicine, Gifu University
Institute
Department

Funding Source
Organization Gifu University
Organization
Division
Category of Funding Organization
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 岐阜大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 03 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 Enrolling by invitation
Date of protocol fixation
2010 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2014 Year 06 Month 01 Day
Date of closure to data entry
2014 Year 06 Month 01 Day
Date trial data considered complete
2014 Year 06 Month 01 Day
Date analysis concluded
2014 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 22 Day
Last modified on
2011 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003732

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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