Acute Ischemic Stroke
Conditions
Interventions
Test group:Treated with the Thrombus Removal System produced by Beijing Taijieweiye Technology Co., Ltd.
Control group:Treated with the Solitaire FR Revascularization Device produced by Medtronic. Inc
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) The subjects were 18 to 80 years old, regardless of gender; (2) The subjects had clinical symptoms and the symptoms were in accordance with acute ischemic stroke, and subjects could not be treated with IV t-PA or the treatment with IV t-PA failed; (3) 8 <= NIHSS <= 29; (4) Acute macrovascular occlusion of intracranial segment of internal carotid artery or middle cerebral artery (within 6 hours of symptom onset), or acute macrovascular occlusion of basilar and / or vertebral artery (within 12 hours of onset of symptom) after confirmed by angiography; (5) The socre of mRS before stroke was 0~2; (6) The subjects were willing to comply with the protocol requirements and data collection procedures; (7) The subjects understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Baseline platelet count 185 mm Hg or diastolic blood pressure > 110 mm Hg); Note: if blood pressure can be adjusted and maintained at acceptable level by drug, patients can be enrolled; (3) Patients unable to tolerate anesthesia, patient with anticoagulant therapy, patients with coagulation dysfunction or patients with symptoms of cerebral hemorrhage; (4) Patients who had serious reactions to contrast agents and were unable to complete pre-treatment medication; or patients who had a definite history of nickel-titanium alloy allergy; (5) Patients who participated in other similar clinical trials and had not yet completed clinical follow-up; or patients who were poor in compliance and unable to complete clinical follow-upjudged by researchers; (6) Pregnant or lactating women; (7) Patients whose life expectancy is less than 6 months, or who are impossible to complete the research as required due to mental illness, cognitive or emotional disorders; (8) Cases that other clinicians think should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vascular recanalization rate immediately after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Good rate of mRS (mRS) 90 days after operation; the time from femoral artery puncture to vascular recanalization or recanalization failure; product performance; | — |
Countries
China
Contacts
Public ContactLiqun Jiao
Xuanwu Hospital, Capital Medical University
Outcome results
None listed