Unique ID issued by UMIN | UMIN000035632 |
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Receipt number | R000040591 |
Scientific Title | Prospective, multi-center, trial of mechanical thrombectomy for acute ischemic stroke using Versi Retriever |
Date of disclosure of the study information | 2019/01/24 |
Last modified on | 2020/10/22 06:13:35 |
Prospective, multi-center, trial of mechanical thrombectomy for acute ischemic stroke using Versi Retriever
Prospective trial of Versi Thrombectomy (VERTH)
Prospective, multi-center, trial of mechanical thrombectomy for acute ischemic stroke using Versi Retriever
Prospective trial of Versi Thrombectomy (VERTH)
Japan |
acute ischemic stroke
Neurology | Radiology | Neurosurgery |
Others
NO
To confirm efficacy and safety of mechanical thrombectomy for acute ischemic stroke using Versi retriever
Safety,Efficacy
Good clinical outcome (modified Rankin score 0-2) and death 90days after procedure
1 successful recanalization after 3 passes of device
2 successful recanalization after procedure
3 new territory emolization related to procedure
4 symptomatic and asymtomatic intracranial hemorrhage 24 hours after procedure
5 symptomatic intracranial hemorrhage 24 hours after procedure
6 good clinical outcome (mRS 0-2 or 10 or more improvement of NIHSS) 90 days after procedure
7 severe adverse event related to device and procedure 90 days after procedure
8 mRS and NIHSS 90days after onset
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
mechanical thrombectomy using Versi Retriever
20 | years-old | <= |
85 | years-old | >= |
Male and Female
1 acute onset neurological symptom related to occluded vessel
2 within 8 hours from onset to treatment or within 24 hours from onset to treatment with imaging diagnosis
3 contra-indication or failed to intravenous rt-PA
4 accessible occlusion at ICA, MCA, VA, BA, PCA
5 5-30 of NIHSS
6 0-2 of mRS before onset
7 obtain documented informed content
1 following condition; arterial dissection, engird, inaccessible turtuousity, difficult access by 50% or more stenosis, acute intracranial hemorrhage, space occping lesion or brain tumor, major early ischemic change in brain
2 occlude 2 major vessel territory
3 allege for contrast media,
4 abnormal PTT/APTT within 4 hours intravenous heparin
5 hemorrhagic tendency or 3 or more INR with Warfarin administration
6 30000cc or less of Platelet
7 50mg/dL or less of blood sugar
8 uncontrolled blood pressure, 185mmHg or more at systolic, 110mmHg or more at diastolic
9 90days or less life expancy
10 pregnant or lactating
11 join another trial of medicine or medical device
12 ineligible for trail
60
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 | 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
Kobe City Medical Center General Hospital
Kobe City Medical Center General Hospital
Local Government
Japan
Kobe City Medical Center General Hospital
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
0783024321
rinken@kcho.jp
NO
広南病院、筑波大学、埼玉医科大学国際医療センター、京都大学、大阪医療センター、兵庫医科大学、神戸市立医療センター中央市民病院、
2019 | Year | 01 | Month | 24 | Day |
Unpublished
Preinitiation
2018 | Year | 12 | Month | 06 | Day |
2019 | Year | 02 | Month | 01 | Day |
2020 | Year | 12 | Month | 31 | Day |
2021 | Year | 03 | Month | 31 | Day |
2021 | Year | 06 | Month | 30 | Day |
2021 | Year | 12 | Month | 31 | Day |
2019 | Year | 01 | Month | 23 | Day |
2020 | Year | 10 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040591
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