UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032939 |
|---|---|
| Receipt number | R000037552 |
| Scientific Title | 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 | 2023/06/14 00:39:04 |
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Basic information
Public title
Usefulness of perfusion measurement using C-arm angiography device in intracerebral endovascular therapy
Acronym
Usefulness of perfusion measurement using C-arm angiography device in intracerebral endovascular therapy
Scientific Title
Usefulness of perfusion measurement using C-arm angiography device in intracerebral endovascular therapy
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shinichi Yoshimmura |
Organization
Hyogo College of Medicine
Division name
Neurosurgery
Zip code
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL
0798-45-6458
s-yoshi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazutaka Uchida |
Organization
Hyogo College of Medicine
Division name
Neurosurgery
Zip code
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL
0798-45-6458
Homepage URL
kuchidans@yahoo.co.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 10 | Day |
Last modified on
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037552
