Post-Market Active Surveillance and Health Economic Evaluation of Cerebrovascular Diagnostic and Therapeutic Devices

The research focuses on "post-market active surveillance and health economic evaluation of non-pharmacological therapies and innovative cerebrovascular diagnostic and therapeutic devices". Partnering with top-tier domestic institutions including the National Medical Administration Center, Regional Drug Evaluation Center, Beijing Tiantan Hospital, Capital Medical University, The First Affiliated Hospital of Naval Medical University, The First Affiliated Hospital of Harbin Medical University, and the School of Public Health, Fudan University, the project intends to: Establish standards for post-market active surveillance of cerebrovascular diagnostic and therapeutic devices and develop an intelligent surveillance system; Build a nationwide collaborative network covering multi-level medical institutions, and conduct serial cohort studies on cerebrovascular diseases based on the surveillance platform; Carry out safety, effectiveness and health economic evaluations for cerebrovascular diagnostic and therapeutic devices using data collected from the network and platform, so as to provide scientific evidence for the full-life-cycle regulation of such devices.

1. Acute Ischemic Stroke Cohort Inclusion Criteria: Age ≥18 years; patients with ischemic stroke receiving acute reperfusion therapy (i.e., endovascular thrombectomy with or without intravenous thrombolysis); informed consent signed by the patient or their legal representative, and availability for follow-up. Exclusion Criteria: Participation in another clinical trial of drugs or devices within the past 3 months or ongoing participation in such trials. 2. Intracranial Arterial Stenosis Cohort Inclusion Criteria: Aged 35-80 years; symptomatic moderate-to-severe intracranial arterial stenosis (50-99%, confirmed by DSA) with contralateral intracranial arterial stenosis \18 years; chronic subdural hematoma confirmed by CT and meeting the indications for middle meningeal artery embolization; patients who provide informed consent for this study and agree to follow-up imaging examinations. Exclusion Criteria: Indications for craniotomy or urgent subdural hematoma evacuation; severe systemic disease with an expected survival time of less than 1 year; history of contrast medium allergy, etc.