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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032939
Receipt No. R000037552
Official scientific title of the study Usefulness of perfusion measurement using C-arm angiography device in intracerebral endovascular therapy
Date of disclosure of the study information 2018/06/11
Last modified on 2018/06/10

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Basic information
Official scientific title of the study Usefulness of perfusion measurement using C-arm angiography device in intracerebral endovascular therapy
Title of the study (Brief title) Usefulness of perfusion measurement using C-arm angiography device in intracerebral endovascular therapy
Region
Japan

Condition
Condition Chronic stage ischemic brain disease (carotid artery stenosis and obstruction, intracranial arterial stenosis and obstruction, Moyamoya disease)
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is to verify that the treatment effect and the treatment policy of a patient can be decided by photographing a perfusion image by using a C arm angiography device immediately after treatment in an angiography room.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Image evaluation scores (5 grades) for each perfusion image
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Take a C-arm perfusion image before starting PTA or CAS treatment
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Chronic phase ischemic brain disease (carotid artery stenosis and obstruction, intracranial artery stenosis and obstruction, Moyamoya disease).
Selection criteria
(1) Patients who undergo intracerebral intravascular examination including SPECT or intracerebral intravascular therapy according to medical necessity
(2) Patients who obtained written consent from participants if they do not have the sufficient consent agreement with the principal or the principal, in writing,
(3) Age: over 20 years old
(4) sex: no question
(5) Separate hospital outpatient: no question
Key exclusion criteria (1) Patients with moderate or higher renal dysfunction (eGFR <45 ml / min / 1.73 m 2)
(2) Patients who are predicted to have allergy by the contrast agent
(3) Other patients who are deemed inappropriate by a doctor
Target sample size 40

Research contact person
Name of lead principal investigator Shinichi Yoshimmura
Organization Hyogo College of Medicine
Division name Neurosurgery
Address 1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL 0798-45-6458
Email s-yoshi@hyo-med.ac.jp

Public contact
Name of contact person Kazutaka Uchida
Organization Hyogo College of Medicine
Division name Neurosurgery
Address 1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL 0798-45-6458
Homepage URL
Email kuchidans@yahoo.co.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization siemens-healthineers
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

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 11 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 05 Month 01 Day
Anticipated trial start date
2017 Year 05 Month 30 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
2018 Year 06 Month 10 Day
Last modified on
2018 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037552

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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