The aim of the study was to establish a clinical and advanced imaging database of acute ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset in China, and to investigate the predictors and potential mechanisms of futile recanalization after mechanical thrombectomy.
The time-window of mechanical thrombectomy for ischemic stroke has extended from 4.5 hours to 24 hours based on the results of the DAWN and DEFUSE 3 trials. However, evidence on the effectiveness and safety of mechanical thrombectomy within 24 hours in the real-world is insufficient. This is a multi-center, prospective, registry cohort study that acute ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset in China. A retrospective dataset was also build in these stroke centers for analysis. A total of 1600 patients with advanced imaging data were anticipated to be enrolled.
Study Type
OBSERVATIONAL
Enrollment
1,600
Yunyun Xiong
Beijing, China
RECRUITINGFavorable functional outcome
proportion of mRS score 0-2 at 3 months. The modified Rankin Scale (mRS) has a minimum value of 0 and maximum value of 6. Higher value indicated worse functional outcome
Time frame: 3 months from stroke onset
Excellent functional outcome at 90 days
proportion of mRS score 0-1 at 3 months
Time frame: 3 months from stroke onset
Ordinal distribution of mRS at 90 days
Number of participants with the ordinal distribution of mRS at 90 days
Time frame: 3 months from stroke onset
EQ-5D score at at 90 days
EQ-5D score at 3 months. EuroQol Five Dimensions Questionnaire scale (EQ-5D score) has a minimum value of 0 and maximum value of 100. Lower value indicated worse functional outcome
Time frame: 3 months from stroke onset
Neurological improvement at 24 hours
NIHSS score \<=1 or improvement of NIHSS score\>=4 compared with baseline NIHSS. National Institution Health Stroke Scale (NIHSS) has a minimum value of 0 and maximum value of 45. Higher value indicated worse severity of neurological impairment.
Time frame: 24 hours from stroke onset
recanalization post-operation
proportion of eTICI 2b50/2c/3. Thrombectomy is a surgical operation using a retrieve stent or aspiration catheter to remove the thrombus inside an occluded vessel and achieve recanalization.The eTICI is a scale to assess the degree of recanalization. So, once the surgeon thought he completed the thrombectomy, he needed to perform a cerebral angiography to assess the degree of recanalization using eTICI.
Time frame: (Day 0) immediately the surgeon thought the thrombectomy completed and performed a second cerebral angiography .
recanalization at 24 hours
proportion of eTICI 2b50/2c/3
Time frame: 24 hours after thrombectomy completed
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