Unique ID issued by UMIN | UMIN000048475 |
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Receipt number | R000055238 |
Scientific Title | Safety and Efficacy of Cerebral Aneurysm Embolization Devices -Observational Study- |
Date of disclosure of the study information | 2022/07/26 |
Last modified on | 2023/08/04 10:42:01 |
Safety and Efficacy of Cerebral Aneurysm Embolization Devices
-Observational Study-
Safety and Efficacy of Cerebral Aneurysm Embolization Devices
-Observational Study-
Safety and Efficacy of Cerebral Aneurysm Embolization Devices
-Observational Study-
Safety and Efficacy of Cerebral Aneurysm Embolization Devices
-Observational Study-
Japan |
cerebral aneurysm
Cerebral arteriovenous malformation
Cerebral arteriovenous fistula
Neurosurgery |
Others
NO
To understand the actual status of use of
detachable coils, which are classified as
electrical detachable coils including i-ED
coil, in Japan in the field of cranial nerve IVR
Safety,Efficacy
1) Aneurysm cases
Reopening rate at 12 months of treatment
2) Arteriovenous malformation and arteriovenous fistula
Reoperation rate at 12 months of treatment
1) In addition to the evaluation of the following items at each time point, the transition and amount of change up to 12 months after treatment will be evaluated.
NIHSS, modified Rankin Scale (mRS), re-treatment or not, Raymond Scale (only for aneurysm cases), loss of venous perfusion (only for arteriovenous fistula cases)
2) Success rate of the procedure
3) Percentage of cases with >50% reduction in size (volume) of arteriovenous malformation immediately after treatment
Observational
18 | years-old | <= |
80 | years-old | > |
Male and Female
1) Male and female patients between the ages of 18 and 80
2) Patients undergoing endovascular treatment with coils for intracranial arterial lesions (aneurysm, arteriovenous malformation, arteriovenous fistula)
3) Patients in whom more than 50% of coils used for endovascular treatment were i-ED coils
4) Patients who have given written consent to participate in this study from the research subjects themselves
1) Patients with significant stenosis (>50%) in the parent extracranial or intracranial artery proximal to the target aneurysm
2) Patients with target aneurysm in the anterior circulation of the proximal portion of the subxiphoid artery
3) Patients who need to leave the neck to maintain blood flow in the bifurcation or branch in the treatment of a target aneurysm
4) Patients undergoing coiling or stenting of non-target lesions within 30 days prior to treatment of the target lesion
5) Patients with multiple aneurysms and treatment of other aneurysms within 30 days of treatment of the target aneurysm under investigation
6) Patients undergoing flow diverter implantation for treatment of target aneurysm to be studied
7) Patients with a Hunt and Hess score of 3 or higher or a modified Rankin Scale (mRS) score of 4 or higher
8) Patients with contraindications to CT or MRI
9) Patients with contraindications to angiography
130
1st name | Kenji |
Middle name | |
Last name | Sugiu |
Okayama University Hospital
Department of Neurological Surgery
700-8558
2-5-1 Shikatacho, Kita-ku, Okayama
086-223-7151
ksugiu@md.okayama-u.ac.jp
1st name | Makoto |
Middle name | |
Last name | Arai |
Nouvelle Place Inc.
-
1050001
3-8-21 Toranomon, Minato-ku, Tokyo
03-6680-2525
i-ED@n-place.co.jp
Kaneka Corporation
Kaneka Corporation
Profit organization
Medical Corporation Rikeikai Yamauchi Clinic Ethics Review Board
1-15-19 Jiyugaoka, Meguro-ku, Tokyo
03-6777-1490
c-irb_ug@neues.co.jp
NO
2022 | Year | 07 | Month | 26 | Day |
Unpublished
Completed
2022 | Year | 07 | Month | 07 | Day |
2022 | Year | 07 | Month | 22 | Day |
2022 | Year | 07 | Month | 22 | Day |
2023 | Year | 06 | Month | 30 | Day |
This study will allow us to understand the actual use of detachable coils, which are classified as electrical detachable type including i-ED coils, in Japan in the field of cranial nerve IVR, and may contribute to future medical advances in the treatment of this area.
2022 | Year | 07 | Month | 26 | Day |
2023 | Year | 08 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055238
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