UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Reserch of Angiographic CT with Intravenous Contrast Injection
Title of the study (Brief title)	Clinical Reserchi of ivACT
Region	Japan

Condition
Condition	Untreated unruptured cerebral aneurysms, untreated stenosis of intracranial arteries, clipped cerebral aneurysms, coiled cerebral aneurysms, stented intracranial arteries
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of angiographic CT with intravenous contrast injection (ivACT) compared with CT angiography (CTA) or MR angiography (MRA).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Various measured values and image quality
Key secondary outcomes	Radiocontrast-induced deterioration in renal function Allergic reaction to contrast agent Other 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	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	angiographic CT with intravenous contrast injection
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients scheduled for CT angiography of untreated unruptured cerebral aneurysm 2) Patients scheduled for CT angiography of untreated intracranial arterial stenosis 3) Patients scheduled for CT angiography of clipped cerebral aneurysm 4) Patients scheduled for MR angiography of coiled cerebral aneurysm 5) Patients scheduled for CT angiography of stented intracranial arterial stenosis
Key exclusion criteria	1) Patient of chronic kidney disease (estimated glomerular filtration rate < 60ml/min/1.73m2) 2) Patient with a history of allergic reaction to contrast agent 3) Pregnant patient or patient who may become pregnant 4) Lactating woman 5) Patient who cannot understand the explanation of study or express one's consent due to impaired consciousness or dementia 6) Patient who is judged as inadequate for the study by responsible person or other members of study
Target sample size	50

Research contact person
Name of lead principal investigator	Tomohito Hishikawa
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Departement of Neurological Surgery
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7336
Email	t-hishi@md.okayama-u.ac.jp

Public contact
Name of contact person	Masafumi Hiramatsu
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Departement of Neurological Surgery
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7336
Homepage URL
Email	tzigane_ravel@yahoo.co.jp

Sponsor
Institute	Departement of Neurological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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	The Japanese Society for Neuroendovascular Therapy
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	岡山大学病院（岡山県）

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 14 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 05 Month 20 Day
Anticipated trial start date	2014 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 07 Month 14 Day
Last modified on	2016 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016774