UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045160 |
|---|---|
| Receipt number | R000051119 |
| Scientific Title | long term results after endovascular occlusion of cerebral arteries |
| Date of disclosure of the study information | 2021/08/31 |
| Last modified on | 2023/09/27 18:30:03 |
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Basic information
Public title
long term results after endovascular occlusion of cerebral arteries
Acronym
cerebral parent artery occlusion: long term results
Scientific Title
long term results after endovascular occlusion of cerebral arteries
Scientific Title:Acronym
cerebral parent artery occlusion: long term results
Region
| Japan |
Condition
Condition
intracranial aneurysms; brain tumor
Classification by specialty
| Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to explore the long term safety and effectiveness of endovascular occlusion of cerebral arteries
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of peri- and postoperative symptomatic stroke.
Key secondary outcomes
the success rate of parent artery occlusion.
the rate of long term morphological change of the other intracranial arteries.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
the patients who received endovascular occlusion of cranial arteries from April 2011 to March 2021 at the participating centers.
Key exclusion criteria
the patients whose follow-up period were less than 2 years.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Nobuhito |
| Middle name | |
| Last name | Saito |
Organization
The University of Tokyo
Division name
Department of Neurosurgery
Zip code
1138655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-8848
nsaito-nsu@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Koizumi |
Organization
The University of Tokyo
Division name
Department of Neurosurgery
Zip code
1138655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
https://www.h.u-tokyo.ac.jp/neurosurg/
sakoizumi-tky@umin.net
Sponsor or person
Institute
Department of Neurosurgery, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
Faculty of Medicine Bldg.2 4F 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
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
| 2021 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.ahajournals.org/doi/full/10.1161/SVIN.123.000968
Publication of results
Published
Result
URL related to results and publications
https://www.ahajournals.org/doi/full/10.1161/SVIN.123.000968
Number of participants that the trial has enrolled
104
Results
Early stroke (within 30 days) occurred in 33 (31.7%) cases. Clinical follow-up over 1 month was available for 85 cases. The incidence of clinical and radiological events was 1.2% and 1.1% per patient year, respectively.
Results date posted
| 2023 | Year | 09 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients who underwent endovascular PAO of their internal carotid or vertebral artery (VA) between April 2011 and March 2022 were included in this observational study.
Participant flow
Information about patient characteristics, details of the endovascular treatment, and clinical and radiological followup were collected.
Adverse events
Not applicable
Outcome measures
Information about patient characteristics, details of the endovascular treatment, and clinical and radiological followup were collected.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
no other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 15 | Day |
Last modified on
| 2023 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051119
