UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003075 |
|---|---|
| Receipt number | 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 16:07:59 |
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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
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
s-yoshi@gifu-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Graduate School of Medicine, Gifu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003732
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
