acute ischemic stroke
Conditions
Interventions
solitaire Group:solitaire stent
MissileEX Group:MissileEX stent
Sponsors
Changhai Hospital (The First Affiliated Hospital of Naval Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-85; 2. Intracranial vascular occlusion confirmed by preoperative DSA: intracranial segment of internal carotid artery (ICA), middle cerebral artery (MCA) M1/M2 segment, anterior cerebral artery (ACA) A1/A2 segment: 3. Preoperative NIHSS score>6 points: 4. Pre-onset mRS score 6 points (non-enhanced CT); 7. Subject or subject's legally authorized representative has signed and dated an Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Life expectancy 3.0 or platelet count 50 seconds): 11. Baseline CT/MMRI suggests intracranial mass effect or intracranial tumor (except meningioma); 12. CT or MRI confirmed intracranial hemorrhage (excluding microbleeding, the researchers will weigh the risk based on the location and number of microbleeding foci to determine whether to enroll); 13. Suspected aortic dissection, suspected septic embolus or bacterial endocarditis; 14. Evidence of intracranial and extracranial cerebral artery dissection or arteritis; 15. Angiography suggests vascular path tortuosity, and the test/control device is difficult to reach the target location 16. Uncontrolled hypertension: systolic blood pressure>185 mmHg and/or diastolic blood pressure>110 mmHg: 17. Blood sugar 22.2 mmol/L; 18. Received thrombin inhibitor treatment within 48 hours before thrombectomy, and partially activated prothrombin time>1.5 times the normal value; 19. Had a history of major surgery within 30 days before enrollment or had a surgical plan within 90 days after enrollment; 20. Other situations judged by the researchers to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful revascularization rate of target vessels (eTICI grades 2b-3); | — |
Secondary
| Measure | Time frame |
|---|---|
| The revascularizationn time of the target vessel (the time from femoral artery puncture to target vessel achieved eTICI = grade 2b);Effective reperfusion rate of target vessel after the first thrombectomy;The degree of improvement in neurological function at 24 hours and 7 days after the operation (NIHSS score);The proportion of patients with mRS score 0-2 after 90 days of surgery; | — |
Countries
China
Contacts
Public ContactJianmin Liu
Changhai Hospital (The First Affiliated Hospital of Naval Medical University)
Outcome results
None listed