Acute ischemic stroke caused by anterior circulation intracranial large vessel occlusion
Conditions
Interventions
Experimental Device:Thrombactomy by Stent Retriever
Control Device:Thrombactomy by Solitaire FR
Sponsors
The First Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years. 2. Symptoms and signs in accordance with anterior circulation ischemia and large vessel occlusion (ICA, MCA-M1 or M2) confirmed by DSA. 3. No obvious disability before onset (Pre-operation modified Rankin Scale(mRS)0-1). 4. NIHSS score >= 6 points at time of randomization. 5. Treatment can be started within 8 hours of onset (randomization complete). (If the onset time of the patient is unknown, for example, when the patient wakes up and finds stroke symptoms, the onset time is taken as the onset of sleep; the patient cannot express the time of onset due to new stroke symptoms such as aphasia and coma, and there are no witnesses beside him, then the time when the patient was last seen in the normal state is taken as the onset time). 6. Written informed consent obtained from patient or patient's legally authorized representative.
Exclusion criteria
Exclusion criteria: 1. Acute posterior circulation cerebral infarction confirmed by CT or MRI. 2. Any type of cerebral hemorrhage (only microbleeds are allowed) on CT or MRI. 3. ASPECTS 22.2 mmol/L. 12. Baseline blood pressure > 185/110 mmHg, or aggressive treatment (intravenous medication) necessary to reduce blood pressure to these limits. 13. Dementia or psychiatric disease that would confound the neurological or functional evaluations. 14. Life expectancy less than 1 year. 15. Current participation in another drug or device research. 16. Severe heart, liver or kidney failure and other serious or terminal illness, and the researchers believe to be not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instant recanalization rate (mTICI 2b-3) after the first thrombectomy;Instant recanalization rate (mTICI 2b-3) after the last thrombectomy;The number of times of stent thrombectomy;The proportion of rescue therapy;Procedure time (randomization complete to recanalization);Change in NIHSS score from baseline at 24-48 hours;Change in NIHSS score from baseline at 7±1 days or discharge;Recanalization situation at 72 hours, as measured by ASPECTS on CT or MRI;The extent of anterior circulation infarction at 24±6 hours, as measured by ASPECTS on CT or MRI;Proportion of functional independence (mRS 0-2) at 90±10 days;Ordinal shift analysis of mRS at 90±10 days; | — |
Countries
China
Contacts
Public ContactHuaizhang Shi
The First Affiliated Hospital of Harbin Medical University
Outcome results
None listed