Acute ischemic stroke caused by anterior circulation intracranial large vessel occlusion
Conditions
Interventions
Experimental:Mechanical thrombectomy with Aspiration Catheter
Sponsors
Department of Interventional Neuroradiology, Beijing Tiantan Hospital, Capital 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. Pre-operation modified Rankin Scale(mRS)0-1. 4. NIHSS score = 6 points at time of randomization. 5.The patients should receive endovascular treatment within 24 hours of estimated time of large vessel occlusion (LVO) onset. If the treatment could happen within 6 hours, the patient should have an ASPECTS = 6 points on non-enhanced CT. If the treatment could happen 6-24 hours after LVO, the patient should meet the condition of CTP/CTA-SI or PWI/DWI mismatch, and have an ASPECTS = 6 points on CTA-SI or DWI. 6. It is recommended for patients without intravenous thrombolysis contraindications to have intravenous thrombolysis with tPA (IVT), if IVT could be started within 4.5 hours of estimated time of LVO. For AIS patients with an unknown time of onset, IVT guided by a mismatch between DWI and FLAIR in the region of ischemia is also recommended. 7. Written informed consent obtained from patient or patient's legally authorized representative.
Exclusion criteria
Exclusion criteria: 1.Acute posterior circulation cerebral infarction comfirmed by CT or MRI. 2.Any type of cerebral hemorrhage (only microbleeds are allowed) on neuroimaging. 3.Large (more than one-third of the MCA) regions of clear hypodensity on the baseline CT scan or ASPECTS 22.2 mmol/L. 15.Baseline blood pressure > 185/110 mmHg, or aggressive treatment (intravenous medication) necessary to reduce blood pressure to these limits. 16.Pregnant or lactating or positive pregnancy test on admission. 17.Dementia or psychiatric disease that would confound the neurological or functional evaluations. 18.Life expectancy less than 1 year. 19.Current participation in another drug or device research. 20.Patients who are referred to the clinical trial center from other hospital, and are not suitable to re-imaging at the center. 21.Other special situations which 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 |
|---|---|
| Proportion of functional independence (mRS 0-2) at 90 days;Ordinal shift analysis of mRS at 90 days;Instant recanalization rate (mTICI 2b-3) after the first aspiration;Instant recanalization rate (mTICI 2b-3) after the last aspiration;The proportion of rescue therapy;Procedure time (femoral artery puncture to recanalization);Change in NIHSS score at 24±2 hours;Change in NIHSS score at 7±1 days or discharge;mTICI grading of target vessel revealed by CTA or MRA at 22-36 hours;The extent of anterior circulation infarction at 22-36 hours, as measured by ASPECTS on CT or MRI; | — |
Countries
China
Contacts
Public ContactZhongrong Miao
Department of Interventional Neuroradiology, Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed