stroke
Conditions
Interventions
Treatment group:Skyflow
Control group:Solitaire
Sponsors
He'nan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2. Clinical signs consistent with acute ischemic stroke; Subject is able to be treated within 8 hours of onset of stroke symptoms; NIHSS = 6?and < 30 at the time of randomization; 3. occlusion in the intracranial internal carotid, or M1/M2 segment of the MCA confirmed by DSA; 4. Prestroke Modified Rankin Score=2; 5. Informed consent of the patient or family member.
Exclusion criteria
Exclusion criteria: 1. CT or MRI evidence of hemorrhage or infarction involving greater than 1/3 of the MCA territory (or in other territories, > 70 ml of tissue on presentation, or CT/DWI-ASPECT 185mmHg or diastolic blood pressure >110mm Hg under the treatment of antihypertensive drug); 6. Baseline platelet count 3; 7. Baseline blood glucose of 22.20mmol/L; 8. Having a heart, lung, liver and kidney function failure or other serious diseases, such as intracranial malignant tumors, intracranial arteriovenous malformation, arteritis, systemic infection, and activity of disseminated intravascular coagulation, with serious disabling stroke within six months, severe mental illness; 9. Can't cooperate with interventional surgery and tolerance; 10. Life expectancy of less than 90 days; 11. Known serious sensitivity to radiographic contrast agents; 12. Female who is pregnant or lactating or has a positive pregnancy test at time of admission; 13. The screening visit is still in the clinical trials involved in other; Participate in other drugs or equipment trials within 3 months before randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recanalization rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| the time from punch to recanalization;the rate of mRS 0-2 at 3 months follow-up;symptomatic intracranial hemorrhage within 24 hours;subarachnoid hemorrhage within 24 hours;all death;severe adverse events;device defect; | — |
Countries
China
Contacts
Public ContactLi Tianxiao
He'nan Provincial People's Hospital
Outcome results
None listed