Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan RCT

Terminated

Phase N/A Results N/A

Update History

28 Feb '18
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
Inclusion Criteria: - 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. - Patients who can receive endovascular treatment within 8 hours after the onset. - Patients whose DWI-ASPECTS was 5 points and more, or CT-ASPECT was 6 points and more just before cerebral angiography. - Patients whose NIHSS is between 8 and 29 points. - Patients who are between 20 and 85 years. - Gender does not matter. - Consent of this study participants must be obtained from patients or legal representative in writing. Exclusion Criteria: - Patients whose neurological symptoms improved and NIHSS is eight points and less after intravenous rt-PA therapy. - Patients whose mRS was 3 points and more before the onset. 3)Patients with past history of lumbar puncture or arterial puncture that were difficult of hemostasis. - Patients with intracranial tumor - Patients with hypersensitivity to contrast agent. - Patients with serious renal disease. - Patients with malignant tumor. - Patients with pregnancy or suspect of pregnancy, or during lactation. - Patients with findings of acute myocardial infarction or pericarditis after myocardial infarction. - Patients who cannot be followed for 3 months. - Patients with past history of cerebral aneurysm, cerebral arteriovenous malformation, cerebral venous thrombosis, or moyamoya disease. - Patients with other occlusions besides ICA or M1 proximal portion. - Patients with aortic dissection complicating endovascular treatment. - Patients with tortuous arteries that prevent the navigation of the device to the target vessel. - Patients considered inappropriate to participate in the study.
Old
Inclusion Criteria: - 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. - Patients who can receive endovascular treatment within 8 hours after the onset. - Patients whose DWI-ASPECTS was 5 points and more, or CT-ASPECT was 6 points and more just before cerebral angiography. - Patients whose NIHSS is between 8 and 29 points. - Patients who are between 20 and 85 years. - Gender does not matter. - Consent of this study participants must be obtained from patients or legal representative in writing. Exclusion Criteria: - Patients whose neurological symptoms improved and NIHSS is eight points and less after intravenous rt-PA therapy. - Patients whose mRS was 3 points and more before the onset. 3)Patients with past history of lumbar puncture or arterial puncture that were difficult of hemostasis. - Patients with intracranial tumor - Patients with hypersensitivity to contrast agent. - Patients with serious renal disease. - Patients with malignant tumor. - Patients with pregnancy or suspect of pregnancy, or during lactation. - Patients with findings of acute myocardial infarction or pericarditis after myocardial infarction. - Patients who cannot be followed for 3 months. - Patients with past history of cerebral aneurysm, cerebral arteriovenous malformation, cerebral venous thrombosis, or moyamoya disease. - Patients with other occlusions besides ICA or M1 proximal portion. - Patients with aortic dissection complicating endovascular treatment. - Patients with tortuous arteries that prevent the navigation of the device to the target vessel. - Patients considered inappropriate to participate in the study.
24 Aug '16
A location was updated in Nishinomiya.
New
The overall status was removed for Hyogo College of Medicine.