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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000017073
Receipt No. R000019803
Scientific Title Post-Market Surveillance of Percutaneous Transluminal Angioplasty and Wingspan Stenting for Intracranial Atheroslerotic Disease
Date of disclosure of the study information 2015/04/10
Last modified on 2016/06/01

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Basic information
Public title Post-Market Surveillance of Percutaneous Transluminal Angioplasty and Wingspan Stenting for Intracranial Atheroslerotic Disease
Acronym WICAD
Scientific Title Post-Market Surveillance of Percutaneous Transluminal Angioplasty and Wingspan Stenting for Intracranial Atheroslerotic Disease
Scientific Title:Acronym WICAD
Region
Japan

Condition
Condition Intracranial Atheroslerotic Disease
Classification by specialty
Neurology Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of percutaneous transluminal angioplasty and stunting using Wingspan stent for intracranial atherosclerotic diseases.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes any death within 30days and ipsilateral stroke from 31 days to 1 year
Key secondary outcomes 1. any death and neurological death within 72 hours and 30 days
2. any stroke, hemorrhagic stroke, ischemic stroke and ipsilateral stroke within 72 hours and 30 days
3. recover of stroke within 3 months
4. restenosis of target lesion within 1 year
5. re-treatment of target lesion within 1 year
6. symptomatic stroke duet restenosis of target lesion within 1 year
7. any adverse event

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 Percutaneous transluminal angioplasty and stenting for
intracranial atheroslerotic disease
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 intracranial atheroslcerotic disease
2 possible to treat with percutaneous transluminal angioplasty and stenting
3 no other effective medical management
4 using Wingspan
Key exclusion criteria no limitation
Target sample size 300

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kazuo Minematsu
Organization National Cerebral and Cardiovascular Center
Division name Cerebrovascular Medicine
Zip code
Address 5-7-1 Fujishirodai, Suita, Osaka 565-8565, Japan
TEL 06-6833-5012
Email kminemat@ncvc.go.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Nobuyuki Sakai
Organization Kobe City Medical Center General Hospital
Division name Neurosurgery
Zip code
Address 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL 078-302-4321
Homepage URL
Email n.sakai@siren.ocn.ne.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization Japanese Society of Neuoendovascular Therapy
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 国立循環器病研究センター(大阪府)、神戸市立医療センター中央市民病院(兵庫県)、虎の門病院(東京都)、他

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 10 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
Date of protocol fixation
2014 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 10 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 08 Day
Last modified on
2016 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019803

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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