Background The management of patients with symptomatic nonacute intracranial artery occlusion (sNA-ICAO), which is a special subset with high morbidity and a high probability of recurrent serious ischemic events despite standard medical therapy (SMT), has been clinically challenging. Some small-sample clinical studies have also discussed endovascular recanalization for sNA-ICAO; however, there is currently a lack of evidence from multicenter, prospective, large-sample cohort trials. The aim of our present study was to evaluate the technical feasibility and safety of endovascular recanalization for sNA-ICAO. Methods and analysis: Our group is currently undertaking a multisite, nonrandomized cohort, prospective registry study enrolling consecutive patients presenting with sNA-ICAO at 15 centers in China between May 1, 2020, and April 30, 2023. A cohort of patients who received SMT and a cohort of similar patients who received ER plus SMT were constructed and followed up for 2 years. The primary outcome is the composite of stroke/TIA within 2 years following enrollment and stroke/TIA ipsilateral to the target vessel. The secondary efficacy outcome includes the following two parts: 1) the incidence of stroke/TIA ipsilateral to the target vessel within 30 days and 90 days in both groups; 2) the all-cause mortality, mRS score, NIHSS score and cognitive function at 30 days, 90 days, 8 months, 12 months and 24 months for both groups, including the MRI, CTA/MRA, CTP or MRP results in patients with internal carotid artery or middle cerebral artery occlusion as well as CTA in patients with basilar or vertebral artery occlusion at 90 days, 12 months and 24 months. Descriptive statistics and linear/logistic multiple regression models will be generated. Clinical relevance will be measured as relative risk reduction, absolute risk reduction and the number needed to treat. Ethics and dissemination This study protocol was reviewed and approved primarily by Beijing Tiantan Hospital, the Capital Medical University Medical Ethics Committee, and the institutional review boards of all partner sites. The study is being externally monitored, and the results will be published in open-access peer-reviewed scientific journals and presented to academic and policy stakeholders.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
453
to recanalize the occlusion cerebral artery with intravascular intervention
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Beijing You 'anmen Hospital
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Liangxiang Hospital
Beijing, Beijing Municipality, China
Handan Central Hospital
Handan, Hebei, China
Hebei Provincial People's Hospital
Shijiazhuang, Hebei, China
ORDOS Central Hospital
Ordos, Inner Mongolia, China
TongLiao City Hospital
Tongliao, Inner Mongolia, China
Jingjiang people's Hospital
Jingjiang, Jiangsu, China
Dalian Municipal Central Hospital
Dalian, Liaoning, China
...and 5 more locations
Primary Outcome
The primary outcome was a composite of any stroke or death within 30 days after enrollment or ischemic stroke in the territory of the qualifying artery from 30 days to 1 year after enrollment.
Time frame: One year
Incidence of Stroke/ TIA Ipsilateral to the Target Vessel
stroke/ TIA ipsilateral to the target vessel will be defined according to the World
Time frame: within 30 days and 90 days in both groups
All-cause Mortality, mRS Score, NIHSS Score and Cognitive Function
to evaluate the change in all-cause mortality, mRS score, NIHSS score and cognitive function in the two groups
Time frame: t 30 days, 90 days, 8 months, 12 months and 24 months for both groups
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