Unique ID issued by UMIN | UMIN000015272 |
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Receipt number | R000017762 |
Scientific Title | Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Randomized Controlled Trial |
Date of disclosure of the study information | 2014/10/01 |
Last modified on | 2018/06/10 19:10:04 |
Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Randomized Controlled Trial
RESCUE-Japan RCT
Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Randomized Controlled Trial
RESCUE-Japan RCT
Japan |
Acute ischemic stroke patients due to IC and M1 proximal occlusion who received intravenous rt-PA therapy within 4.5 hours after onset
Medicine in general | Cardiology | Neurology |
Radiology | Neurosurgery | Emergency medicine |
Rehabilitation medicine |
Others
NO
The aim of this study is to clarify the efficacy of the endovascular treatment for acute ischemic stroke patients with large vessel occlusion and are not respond to intravenous recombinant tissue plasminogen activator (rt-PA) therapy.
Efficacy
Shift analysis of modified Rankin Scale at 90 days after onset
(1)The rate of mRS 0-2 at 90 days (+/- 10 days) after onset
(2)Death within 90 days (+/- 10 days) after onset.
(3)Revascularization rates of the target vessel
(4)Symptomatic intracranial hemorrhage within 72 hours (+/- 8 hours) after onset.
(5)The difference of NIHSS score between pre-treatment and at 72 hours (+/- 8 hours) after onset.
(6)Other adverse events
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Maneuver |
Group with additional endovascular treatment
Group without additional endovascular treatment
20 | years-old | <= |
85 | years-old | >= |
Male and Female
1) Acute ischemic stroke patients who were treated with intravenous rt-PA therapy within 4.5 hours from onset and have persistent occlusion of IC and M1 proximal portion* confirmed by cerebral angiography.
*: M1 proximal portion means the segment of MCA within 5mm from the internal carotid bifurcation.
2) Patients who can receive endovascular treatment within 8 hours after the onset.
3) Patients whose DWI-ASPECTS is 5 points or more, or CT-ASPECT is 6 points or more just before cerebral angiography.
4) Patients whose NIHSS is between 8 and 29 points.
5) Patients who are between 20 and 85 years.
6) Gender does not matter.
7) Consent of this study participants must be obtained from patients or legal representative in writing.
1)Patients whose neurological symptoms improved and NIHSS is eight points or less after intravenous rt-PA therapy.
2)Patients whose mRS is 3 points or more before the onset.
3)Patients with past history of lumbar puncture or arterial puncture that were difficult of hemostasis.
4)Patients with intracranial tumor
5)Patients with hypersensitivity to contrast agent.
6)Patients with serious renal disease.
7)Patients with malignant tumor.
8)Patients with pregnancy or suspect of pregnancy, or during lactation.
9)Patients with findings of acute myocardial infarction or pericarditis after myocardial infarction.
10)Patients who cannot be followed for 3 months.
11)Patients with past history of cerebral aneurysm, cerebral arteriovenous malformation, cerebral venous thrombosis, or moyamoya disease.
12)Patients with other occlusions besides ICA or M1 proximal portion.
13)Patients with arterial dissection complicating endovascular treatment.
14)Patients with tortuous arteries that disturb navigation of the device to the target vessel.
15)Patients considered inappropriate to participate in the study.
200
1st name | |
Middle name | |
Last name | Shinichi Yoshimura , Nobuyuki Sakai |
Hyogo College of Medicine
Department of Neurosurgery
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
0798-45-6458
rescue-j@hyo-med.ac.jp
1st name | |
Middle name | |
Last name | Kazutaka Uchida |
Hyogo College of Medicine
Department of Neurosurgery
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
0798-45-6458
http://rescue-japan.jp/index.asp
kuchida@hyo-med.ac.jp
Department of Neurosurgery
Hyogo College of Medicine
Health, Labor and Welfare Research Institute expenses
Government offices of other countries
Japan
Hyogo College of Medicine Clinical Research Support Center
The Japanese Society for NeuroEndovascular Therapy
NO
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済生会長崎病院、埼玉医科大学国際医療センター、札幌医科大学、シミズ病院、順天堂大学順天堂医院、西湘病院、国立病院機構仙台医療センター、康生会武田病院、田主丸中央病院、多摩総合医療センター、徳島大学、虎ノ門病院、名古屋大学、名古屋第二赤十字病院、日本医科大学、函館新都市病院、函館脳神経外科病院、兵庫医科大学、兵庫県立姫路循環器病センター
弘前大学、広島大学、福井赤十字病院、福岡大学筑紫病院、マツダ病院、三重大学病院、都城市郡医師会病院、山口県立総合医療センター、山口大学、横浜新都市脳神経外科病院
2014 | Year | 10 | Month | 01 | Day |
Unpublished
Terminated
2014 | Year | 09 | Month | 20 | Day |
2014 | Year | 10 | Month | 01 | Day |
2014 | Year | 09 | Month | 28 | Day |
2018 | Year | 06 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017762
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