UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017073
Receipt number 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 11:03:35

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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

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

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 or person

Institute

National Cerebral and Cardiovascular Center

Institute

Department

Personal name



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

Value
https://center6.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