acute ischemic stroke
Conditions
Interventions
Single arm group:Thrombus aspiration catheter system
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years old; 2. In acute ischemic stroke, preoperative imaging (CTA/DSA/MRA) confirmed intracranial large vessel occlusion (intracranial segment of internal carotid artery, A1 segment of anterior cerebral artery, middle cerebral artery) that caused the ischemic stroke. Arterial M1 or M2 segment, where A1 and M2 segments are determined by the doctor); 3. It is estimated that the time from the onset of the patient to the puncture is less than 24 hours; 4. The patient meets one of the following conditions: (1) Time from onset to puncture = 6 points; NIHSS >= 6 points (on admission) and mRS < 2 points before the onset; (2) 6 hours < onset to puncture time <= 16 hours, meeting the inclusion criteria of DAWN or DEFUSE3 studies; (3) 16 hours < onset to puncture time <= 24 hours, meeting the inclusion criteria of the DAWN study; 5. Patients or guardians voluntarily participate in this clinical trial and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. The stroke is accompanied by epilepsy; 2. History of intracranial hemorrhage or subarachnoid hemorrhage on the same side of the onset in the past 3 months; 3. There is a history of intracranial tumor, cerebral arteriovenous malformation or aneurysm, and no surgical treatment; 4. Known to have one or more of the following allergies/resistances or contraindications: antiplatelet drugs/anticoagulants/contrast agents and/or anesthetics; 5. Known allergies to medical devices and related products (allergies to materials such as nickel-titanium metal or its alloys); 6. Active bleeding or known bleeding tendency (such as: receiving anticoagulation therapy or coagulation dysfunction before surgery, INR>3.0, except for patients who received thrombolysis before surgery); 7. Platelet count is lower than 40x10^9/L; 8. Known severe heart, liver and kidney failure; 9. Associated with ST segment elevation myocardial infarction or serious infection (endocarditis or sepsis); 10. Gastrointestinal or urinary system bleeding within the past 1 month; 11. After treatment, blood glucose concentration 22.2 mmol/L; 12. Life expectancy caused by other diseases < 90 days; 13. Pregnant, lactating women or women planning to become pregnant in half a year; 14. Known to have dementia or mental illness and unable to complete neurological evaluation; 15. Patients who are participating in clinical research of other drugs or devices; 16. For other reasons, the researcher believes that patients are not suitable to participate in this project. 17. Imaging exclusion criteria: (1) Imaging examinations indicate that the infarct size is greater than 1/3 of the MCA blood supply area or the mass effect of the lesion significantly leads to the displacement of the midline structure; (2) Intracranial hemorrhage or subarachnoid hemorrhage confirmed by imaging examination (microbleeding is not counted, or the surgeon judges based on clinical experience); (3) Imaging shows simultaneous acute occlusion of bilateral carotid systems; tandem lesions of simultaneous occlusion of intracranial and extracranial vessels; (4) The target vessel is known or suspected to be chronic occlusion; (5) Other difficulties make the test device unable to reach the target blood vessel or difficult to recover.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of target vessel confirmed by DSA immediately after surgery(mTICI 2b-3); | — |
Countries
China
Contacts
Public ContactMiao Zhongrong
Department of Interventional Neuroradiology, Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed