Acute Ischemic strok
Conditions
Interventions
Sponsors
Xuanwu Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients over 18 years old; 2. The time of onset = 6 (non enhanced CT), NIHSS >= 6 (on admission), and Mrs <= 2 (before onset); 4. Patients with occlusion of large intracranial vessels (intracranial segment of internal carotid artery, M1 / m2 segment of middle cerebral artery, basilar artery and intracranial segment of vertebral artery) confirmed by DSA; 5. Patients or their legal representatives who can understand the purpose of the trial, voluntarily participate in and sign the written informed consent, and can accept the follow-up.
Exclusion criteria
Exclusion criteria: Clinical exclusion criteria: 1. Patients with epilepsy during stroke; 2. Patients with life expectancy less than 90 days; 3. Patients with intracranial hemorrhage or subarachnoid hemorrhage on the same side in recent 3 months; 4. Patients with previous history of intracranial tumor, cerebral arteriovenous malformation or aneurysm were not treated with surgery; 5. Patients with a history of cerebral infarction or myocardial infarction or uncontrolled serious infectious diseases (such as endocarditis or septicemia) in recent 3 months; 6. Patients with gastrointestinal or urinary tract bleeding in the past three weeks; 7. Patients who have participated in clinical trials of other drugs or devices and have not been withdrawn or withdrawn from the group within the first three months of the screening period of this trial; 8. Patients with serious mental history, heart, liver, lung and kidney failure or other serious diseases; 9. Patients with active bleeding or known bleeding tendency (INR > 3.0 or platelet count 50 seconds); 10. The blood glucose which could not be controlled by drugs was less than 2.7 mmol / L or more than 22.2 mmol / L; 11. Patients with hypertension beyond the control of drugs (systolic blood pressure > 180 mmHg, or diastolic blood pressure > 105 mmHg); 12. Pregnant women of childbearing age are positive or in lactation; 13. Patients who are known to be allergic or resistant to contrast agents, anesthetics, anticoagulants, and antiplatelet drugs; 14. Patients who have undergone major surgical operations in the past month; 15. Other cases with unknown onset time or unsuitable for inclusion in the group judged by researchers. Imaging exclusion criteria 1. Patients with intracerebral hemorrhage confirmed by CT / MRI (except for microbleeds, the researchers determined whether to enter the group after weighing the risk according to the location and number of microbleeds), large area infarction (aspects = 70ml or core infarction area > 1 / 3 of middle cerebral artery); 2. Patients with common carotid artery occlusion who are known or suspected to be chronic occlusion; 3. DSA showed that bilateral carotid system was occluded at the same time; 4. DSA showed (or highly suspected) carotid dissection or arteritis; 5. DSA showed that the vascular route was tortuous, and the test instrument was difficult to reach the target position or recover.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of arterial recanalization of the occluded target vessel immediately post procedure (the recanalization is defined as modified Thrombolysis in Cerebral Infarction (mTICI) score equal or superior to 2b/3 following the aspiration with the study device and remedial procedures if necessary. ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of 90-day good functional outcome (defined by a modified Rankin score mRS=2);Time to achieve revascularization (from groin puncture to recanalization of the occluded target vessel defined as mTICI 2b/3);Percentage of arterial recanalization of the occluded target vessel after the first aspiration and the third aspiration (the recanalization is defined as mTICI 2b/3);NIHSS score improvement at 24h, 7-day or the time of discharge (whichever comes first);Percentage of using rescue procedures (After three times of aspiration, the recanalization has not achieved, i.e. mTICI is lower than 2b/3, the remedial procedure, Stent Retrieval, is utilized.); | — |
Countries
China
Contacts
Public ContactLiqun Jiao
Xuanwu Hospital of Capital Medical University
Outcome results
None listed