Unique ID issued by UMIN | UMIN000040681 |
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Receipt number | R000046431 |
Scientific Title | Multi center registry of flow diverter treatment for intracranial aneurysms using FRED, initial experience in Japan |
Date of disclosure of the study information | 2020/06/10 |
Last modified on | 2020/06/07 18:52:11 |
Multi center registry of flow diverter treatment for intracranial aneurysms using FRED, initial experience in Japan
Post market surveillance of FRED
Multi center registry of flow diverter treatment for intracranial aneurysms using FRED, initial experience in Japan
FRED PMS
Japan |
intracranial aneurysm
Radiology | Neurosurgery |
Others
NO
To investigate safety and efficacy of initial experience of flow diverter treatment for intracranial aneurysm using FRED in Japan
Safety,Efficacy
stroke and death within 30 days after treatment
1. complete occlusion at 1 year after treatment
2. symptomatic stroke within 1 year after treatment
3, neurological death within 1 year after treatment
4. complete occluuion at 3 year after treatment
5. rupture of target aneurysm
6. re-treatment of target aneurysm
7. change in modified Rankin Scale
8. Severe adverse event within 1 year related to device
9. device failure
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1 intracranial aneurysm
2 treated using FRED
reject for registration by patient or family
300
1st name | Nobuyuki |
Middle name | |
Last name | Sakai |
Kobe City Medical Center General Hospital
Neurosurgery
650-0047
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
078-302-4321
n.sakai@siren.ocn.ne.jp
1st name | Nobuyuki |
Middle name | |
Last name | Sakai |
Kobe City Medical Center General Hospital
Neurosurgery
650-0047
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
078-302-4321
n.sakai@siren.ocn.ne.jp
Kobe City Medical Center General Hospital
Japanese Society of Neuoendovascular Therapy
Self funding
Japan
Kobe City Medical Center General Hospital
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
078-302-4321
rinken@kcho.jp
NO
広南病院(宮城県)、筑波大学(茨城県)、順天堂大学(東京都)、愛知医科大学(愛知県)、京都大学(京都府)、国立循環器病センター(大阪府)、大阪医療センター(大阪府)、兵庫医科大学(兵庫県)、神戸市立医療センター中央市民病院(兵庫県)、岡山大学(岡山県)、福岡大学筑紫病院(福岡県)
2020 | Year | 06 | Month | 10 | Day |
Unpublished
Preinitiation
2020 | Year | 06 | Month | 07 | Day |
2020 | Year | 07 | Month | 01 | Day |
2021 | Year | 12 | Month | 31 | Day |
retrospective registry of initial experience of flow diverter treatment using FRED in Japan
2020 | Year | 06 | Month | 07 | Day |
2020 | Year | 06 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046431
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