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) MCA-M1 or -M2 occlusion proved by CTA/MRA; 4) Eligible for intravenous thrombolysis with TNK-tPA; 5) Time from stroke onset to randomization within 4.25 hours; 6) Written informed consent is obtained from patients and/or their legal representatives.
Exclusion criteria
Exclusion criteria: (1) CT or MR evidence of intracranial hemorrhage; (2) Contraindications of intravenous Tenecteplase; (3) Pre-morbidity with a modified Rankin scale score >= 2; (4) Currently in pregnant or lactating or serum beta HCG test is positive on admission; (5) Contraindication 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) Patients with occlusions in multiple vascular territories (e.g. bilateral anterior circulation, or anterior/posterior circulation); (9) CT or MR evidence of mass effect or intracranial tumor (except small meningioma); (10) CT or MR evidence of cerebral vasculitis; (11) CT or MR angiography 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 |
|---|---|
| modified Rankin scale score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Substantial reperfusion at initial angiogram;Revascularization rates at 24 hours from randomization;Improvement in NIHSS between baseline and 24 hours, and 5~7d;Symptomatic/Asymptomatic intracranial hemorrhage within 48 hours;Parenchymal hematoma;Mortality within 90 days;Procedural-related complication and severe adverse events; | — |
Countries
China
Contacts
Xinqiao Hospital of the Army Medical University