Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Randomized Controlled Trial
- Conditions
- Acute ischemic stroke patients due to IC and M1 proximal occlusion who received intravenous rt-PA therapy within 4.5 hours after onset
- Registration Number
- JPRN-UMIN000015272
- Lead Sponsor
- Department of Neurosurgery Hyogo College of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Shift analysis of modified Rankin Scale at 90 days after onset
- Secondary Outcome Measures
Name Time Method (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