Acute Ischemic strok
Conditions
Interventions
Sponsors
Xuanwu Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18-80 years. 2. With acute ischemic stroke, preoperative imaging (CTA/DSA/MRA) confirms anterior circulation (internal carotid artery or middle cerebral artery M1 or M2 segment occlusion, M2 segment according to physician's diagnosis) and posterior circulation vascular occlusion (basal artery tip, unconscious disorder). 3. NIHSS score >= 6 and mRS < 2 before stroke onset. 4. Expected onset to femoral artery puncture completion time <= 6 hours; 5. Informed consent signed by patient or guardian.
Exclusion criteria
Exclusion criteria: 1. Imaging examination clearly shows early anterior circulation large area cerebral infarction (imaging examination showed infarct area >= 70ml or infarct volume > 1/3 MCA blood supply area) or focal space occupying lesion effect significantly led to displacement of the midline structure; 2. Imaging examination confirmed intracranial hemorrhage or subarachnoid hemorrhage (excluding microhemorrhage on SWI, or assessed by clinical experience); 3. Imaging shows simultaneous acute occlusion of bilateral carotid arteries; tandem lesions with simultaneous occlusion of intracranial and extracranial vessels; 4. Patients with disturbance of consciousness of posterior circulation vascular occlusion, NIHSS consciousness level score (1a=3); 5. Angiography shows occlusion of an intracranial artery due to arterial dissection or arteritis; 6. The vessel tortuosity or other difficulty of the vessel prevent the test device from reaching the target vessels. 7. One or more of the following allergies/resistances or contraindications are known: antiplatelet agents/anticoagulation/contrast agents and/or anesthetics; 8. Patient is known to be allergic to medical devices and related products; (allergic to materials such as nickel-titanium or its alloys); 9. Active bleeding or known bleeding tendency (e.g, preoperative anticoagulant therapy or coagulation dysfunction before operation, INR > 3.0, except for patients receiving thrombolysis before surgery); 10. The platelet count is lower than 40 x 10^9/L; 11. A history of severe heart, liver, kidney dysfunction; 12. With ST-segment elevation myocardial infarction or severe infection (endocarditis or sepsis); 13. Major surgery has been performed in the past 1 month; 14. There is gastrointestinal or urinary bleeding within 1 month; 15. Hypertension beyond control of drug treatment (systolic blood pressure persists >= 185 mmHg or diastolic blood pressure persists >= 110mmHg); 16. blood glucose concentration 22.2 mmol/L after treatment; 17. Life expectancy < 3 months; 18. Pregnant women or women who plan to become pregnant in half a year (by asking about medical history, pregnancy tests are only used when necessary.); 19. Patients with dementia or mental illness cannot complete the assessment of neurological function; 20. Patients who are participating in clinical studies of other drugs or devices; 21. Any other reasons, why the investigator believes it is not suitable for patients to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target vessel satisfactory reperfusion rate (mTICI 2b-3 ratio); | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-care rate at 7 days after surgery or at discharge, and at 90 days (ratio of mRS 0-2 points);Satisfactory reperfusion rate of target vessels after the first aspiration (ratio of mTICI 2b-3);Satisfactory reperfusion rate of the target vessel after the last aspiration (ratio of mTICI 2b-3);Target vessel satisfactory reperfusion time: Time to start treatment (Completion of femoral artery puncture) to target vessel satisfactory reperfusion (Grade mTICI 2b-3);Proportion of remedial treatment.;Changes in NIHSS from 24-36 hours after surgery.;Changes in NIHSS 7 days after surgery or at discharge (whichever occurs first);The success rate of device use: refers to the smooth delivery of the aspiration catheter system to the occlusive segment of the vessel, the successfully retrieved catheter system, and calculating the proportion of all devices successfully used.;Device defect rate: Device defects are defined as a failure of a medical device to meet its performance specification or otherwise perform as intended, including, but not limited to, label errors, quality problems, sterile packaging barrier breakage, and malfunctions;Surgery success rate: Successful operation means that the mTICI of the blood vessel after the final treatment is grade 2b or 3 (allowing the use of adjuvant therapy). The rate is calculated using the proportion of successful cases.; | — |
Countries
China
Contacts
Public ContactLiqun Jiao
Neurosurgery, Xuanwu Hospital, Capital Medical University
Outcome results
None listed