UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective Registry of Percutaneous Transluminal Angioplasty for Intracranial Atheroslerotic Disease
Title of the study (Brief title)	AICAD
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 without 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 dueto restenosis of target lesion within 1 year 7. any adverse event

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 without using Wingspan
Key exclusion criteria	no limitation
Target sample size	300

Research contact person
Name of lead principal investigator	Nobuyuki Sakai
Organization	Kobe City Medical Center General Hospital
Division name	Neurosurgery
Address	2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL	078-302-4321
Email	n.sakai@siren.ocn.ne.jp

Public contact
Name of contact person	Nobuyuki Sakai
Organization	Kobe City Medical Center General Hospital
Division name	Neurosurgery
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	Kobe City Medical Center General Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 10 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 11 Month 01 Day
Anticipated trial start date	2016 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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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=R000019801