Acute ischemic stroke
Conditions
Interventions
test team:Intracranial embolectomy stent
control group:Solitaire FR
Sponsors
The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: General selection criteria: 1. >=18 years old; 2. NIHSS >= 6 at randomization; 3. Mrs =6 should be >= 6; 8. When it is more than 6 h but not more than 24 h (inclusive) from the onset of stroke to the completion of femoral artery puncture, refer to the imaging CTP/MRP in "Guidelines for Early Intravascular Interventional Diagnosis and Treatment of Acute Ischemic Stroke in China 2022" for evaluation, and at the same time meet ASPECTS >=6 points; 9.DSA showed acute occlusion of internal carotid artery, M1 and M2 segments of middle cerebral artery, A1 and A2 segments of anterior cerebral artery, basilar artery and vertebral artery.
Exclusion criteria
Exclusion criteria: General exclusion criteria: 1. Neither MRI nor CT can be performed; 2. Severe persistent hypertension that cannot be controlled by drug treatment, i.e. SBP lasting more than 185 mmHg and/or DBP lasting more than 110 mmHg;; 3. Blood sugar 22.20 mmol/L (400 mg/dl); 4. Decreased platelet count ( 1 vessel was occluded (for example, bilateral internal carotid arteries were occluded at the same time, or the intracranial vessels of anterior circulation and posterior circulation were occluded at the same time, or the intracranial and extracranial segments of internal carotid arteries were occluded at the same time, or the intracranial and extracranial segments of vertebrobasilar arteries were occluded at the same time); 15. Angiography showed intracranial arterial occlusion caused by arterial dissection or arteritis; 16. The blood vessels in the pathway are seriously tortuous, and it is difficult for the test/control instrument to reach the target position.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immediate vascular recanalization success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 90 days after operation, mRS 0-2 score ratio.;The time from femoral artery puncture to vascular recanalization or the end time of surgery for subjects with no vascular recanalization.;Percentage of subjects whose NIHSS score decreased by > 4 points;Instrument operation success rate;Surgical success rate;Incidence of symptomatic intracranial hemorrhage in 24 hours after operation;Incidence of asymptomatic intracranial hemorrhage in 24 hours after operation;24 h after operation, all-cause mortality;All-cause mortality 90 days after operation;Incidence of adverse events and serious adverse events.;Incidence rate of instrument defects; | — |
Countries
China
Contacts
Public ContactJianmin Liu
The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
Outcome results
None listed