Unique ID issued by UMIN | UMIN000043166 |
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Receipt number | R000049273 |
Scientific Title | Multi center registry of flow diverter treatment for intracranial aneurysms using FRED, initial post market surveillance in Japan |
Date of disclosure of the study information | 2021/01/28 |
Last modified on | 2021/01/28 17:28:05 |
Multi center registry of flow diverter treatment for intracranial aneurysms using FRED,
initial post market surveillance in Japan
Multi center registry of efficacy and safety of FRED
Multi center registry of flow diverter treatment for intracranial aneurysms using FRED,
initial post market surveillance in Japan
Multi center registry of efficacy and safety of FRED
Japan |
cerebral aneurysm
Neurosurgery |
Others
NO
To investigate the safety and efficacy of the initial experience of flow diverter placement for cerebral aneurysms using FRED in Japan.
Safety,Efficacy
Death and occurrence of all stroke, within 30days after treatment
Observational
Not applicable |
Not applicable |
Male and Female
Patients with cerebral aneurysm who underwent FD placement using FRED
Patients who refuses to register
200
1st name | Nobuyuki |
Middle name | |
Last name | Sakai |
Kobe City Medical Center General Hospital
Neurosurgery
6500047
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
078-302-4321
n.sakai@siren.ocn.ne.jp
1st name | Chiaki |
Middle name | |
Last name | Sakai |
Kobe City Medical Center General Hospital
Center for Clinical Research and Innovation
6500047
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
078-302-4321
chiakimk@cronos.ocn.ne.jp
Kobe City Medical Center General Hospital
Japanese Society of Neuoendovascular Therapy
Non profit foundation
Kobe City Medical Center General Hospital
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
078-302-4321
rinken@kcho.jp
NO
2021 | Year | 01 | Month | 28 | Day |
Unpublished
Enrolling by invitation
2020 | Year | 12 | Month | 10 | Day |
2020 | Year | 12 | Month | 15 | Day |
2021 | Year | 02 | Month | 08 | Day |
2026 | Year | 03 | Month | 31 | Day |
Observations: Complete occlusion of target cerebral aneurysm 12 months after treatment, onset of target cerebral aneurysm and treatment-related stroke within 1 year after treatment, onset of neuronal death within 1 year after treatment, 36 months after treatment Complete occlusion of the target cerebral aneurysm within 36 months, rupture of the target cerebral aneurysm within 36 months after treatment, retreatment of the target cerebral aneurysm within 36 months after treatment, serious device-related events, equipment malfunction
2021 | Year | 01 | Month | 28 | Day |
2021 | Year | 01 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049273
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