acute ischemic stroke
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Aged 18 years or older; 2) Anterior circulation acute ischemic stroke confirmed by clinical symptoms or imaging examination; 3) I-ICA or MCA-M1 occlusion proved by CTA/MRA/DSA; 4) Eligible for intravenous thrombolysis with r-tPA; 5) Time from stroke onset to randomization within 4.25h; 6) Written informed consent is obtained from patients and/or their legal representatives.
Exclusion criteria
Exclusion criteria: 1) Intracranial hemorrhage; 2) Contraindications of IV rt-PA; 3) Pre-stroke disability mRS score >= 2; 4) Pregnancy or lactating women; 5) Known sensitivity to radiographic contrast agents, nickel, titanium metals or their alloys;; 6) Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel; 7) Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations; 8) Subjects with occlusions in multiple vascular territories (e.g. bilateral anterior circulation, or anterior/posterior circulation); 9) CT or MRI evidence of mass effect or intracranial tumor (except small meningioma); 10) CT or MRI evidence of cerebral vasculitis; 11) CTA or MRA evidence of intracranial arteriovenous malformations or aneurysms; 12) Any terminal illness with life expectancy less than 6 months; 13) Unlikely to be available for 90-day follow-up; 14) Current participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mRS score 0–1 vs. 2-6 at 90 days;Symptomatic intracerebral hemorrhage rate within 48 h;Mortality rate at 90 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| mRS score 0–1 vs. 2-6 at 90 days;Shift in the distribution of mRS scores at 90 days in treatment versus controls;Vessel recanalization rate evaluated by CTA or MRA within 48h;NIHSS score at 24 h;NIHSS score at 5–7 days;EQ-5D at 90 days;Successful recanalization proportion immediate after EVT; | — |
Countries
China
Contacts
Xinqiao Hospital, the Third Military Medical University