Acute ischemic stroke
Conditions
Interventions
Treatment group:Mechanical thrombectomy Systems (NeuroVasc Technolohies Inc.)
Control group:Intracranial thrombectomy stent (Trade name: Solitare FR)
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Clinical symptoms and signs consistent with acute ischemic stroke; 2. The mRS score before the occurrence of this acute ischemic stroke is <=1 point; 3. Aged 18 to 85 years; 4. 6 points <= NIHSS score < 30 points; 5. It is expected to be able to complete arterial puncture within 8 hours of onset; 6. The imaging examination needs to meet the requirements of MR/CT: infarct core volume < 70ml; or ASPECTS score of 6 to 10; 7. DSA angiography confirmed: ICA (intracranial segment), MCA (M1 or M2) or ACA (A1 or A2) occlusion; 8. Subjects who can receive IV-tPA treatment should receive IV-tPA treatment, and require: within 4.5 hours of stroke onset, the investigator confirms that the subject has/is receiving the correct dose of IV-tPA treatment; 9. The subjects or their legal representatives can understand the purpose of the trial, voluntarily participate and sign the written informed consent, and can be followed up.
Exclusion criteria
Exclusion criteria: 1. Life expectancy may be less than 90 days; 2. Women who are pregnant or breastfeeding, or who plan to have children within the next 90 days; 3. Allergic to materials such as contrast agents, nickel-titanium metal or its alloys; 4. Suspected renal failure. Renal failure was defined as serum creatinine > 3.0 ngdL (264 µmol LD or glomerular filtration rate (GFR) 185 mmHg or diastolic blood pressure ~ 10 mH) that cannot be controlled by drug treatment; 6. Those with active bleeding or known bleeding tendency; 7. Platelet count 400mg/dL (22.20 mmolL); 9. Subjects with occlusion in multiple vascular regions (eg, bilateral anterior circulation or anterior/posterior circulation); 10. CT or MR indicates intracranial hemorrhage or large-area cerebral infarction (infarct volume >= 70ml or infarct volume > 13MCA blood supply area); 11. Inability to obtain accurate NIHSS assessment results at the onset of stroke; 12. Angiography showing occlusion of an intracranial artery due to arterial dissection or arteritis; 13. DSA angiography shows that the vascular path is tortuous, and the test/control device is difficult to reach the target position or difficult to recover; 14. Embolism presumed to be caused by septic emboli or bacterial endocarditis; 15. CT or MR shows the presence of intracranial tumors (except small meningiomas); 16. Received any thrombectomy device or other intra-arterial (neurovascular) therapy within the last three months; 17. Unable to complete 90 ± 14 days of follow-up; 18. Stroke within the past 3 months; 19. Previous clinical manifestations of AVM rupture or aneurysm rupture; 20. Severe organic diseases such as heart, lung and kidney; twenty one. Participating in clinical trials of other drugs or devices who have not completed the primary study endpoint; twenty two. Other circumstances that the investigator judges not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recanalization rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time from puncture to recanalization;NIHSS scores at 24±6 hours after surgery, 7±2 days after surgery or before discharge;Proportion of mRS(0-2 points) subjects at 90±14 days after surgery;Instrument success rate;Operative successful rate;Incidence of distal vascular embolism events;the incidence of intraoperative ectopic thrombotic events;Number of thrombectomy; | — |
Countries
China
Contacts
Public ContactLi Tianxiao
Henan Provincial People's Hospital
Outcome results
None listed