Acute ischemic stroke patients due to IC and M1 proximal occlusion who received intravenous rt-PA therapy within 4.5 hours after onset
Conditions
Interventions
Group with additional endovascular treatment
Group without additional endovascular treatment
Sponsors
Department of Neurosurgery Hyogo College of Medicine
Hyogo College of Medicine Clinical Research Support Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shift analysis of modified Rankin Scale at 90 days after onset | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
Japan
Contacts
Public ContactKazutaka Uchida
Hyogo College of Medicine Department of Neurosurgery
Outcome results
None listed