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NCT07828379

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

Sponsor: Changhai Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2026-09-01

Completion Date

2028-09-01

Last Updated

2026-09-18

Healthy Volunteers

Conditions

Acute Ischemic Stroke Intracranial Arterial Stenosis Extracranial Arterial Stenosis Intracranial Aneurysms Chronic Subdural Hematoma

Interventions

PROCEDURE

Endovascular Treatment for Acute Ischemic Stroke

Middle Meningeal Artery Embolization for Chronic Subdural Hematoma；Flow-Diverter Implantation；Coil Embolization；Endovascular Embolization of Intracranial Aneurysm；Extracranial Arterial Angioplasty and Stenting；Percutaneous Transluminal Angioplasty；Percutaneous Transluminal Angioplasty and Stenting；Intracranial Arterial Stenting.

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 \<50%. Symptomatic stenosis is defined as transient ischemic attack (TIA), stroke or other relevant neurological symptoms caused by internal carotid artery stenosis within the preceding 6 months; informed consent signed by the patient or their legal representative, and availability for follow-up. Exclusion Criteria: Contraindications to stenting; participation in another clinical trial of drugs or devices within the past 6 months or ongoing participation in such trials. 3. Extracranial Arterial Stenosis Cohort Inclusion Criteria: Aged 35-80 years; symptomatic moderate-to-severe stenosis (50-99%) of the origin of the internal carotid artery or vertebral artery confirmed by ultrasound, CTA or DSA. Symptomatic stenosis is defined as transient ischemic attack (TIA), stroke or other relevant neurological symptoms caused by stenosis of the internal carotid artery or vertebral artery within the preceding 6 months; asymptomatic severe stenosis (70%-99%) of the origin of the internal carotid artery or vertebral artery; informed consent signed by the patient or their legal representative, and availability for follow-up. Exclusion Criteria: Contraindications to interventional therapy including stenting or balloon angioplasty; participation in another clinical trial of drugs or devices within the past 6 months or ongoing participation in such trials. 4. Intracranial Aneurysm Cohort Inclusion Criteria: Age ≥18 years; ruptured or unruptured intracranial aneurysm diagnosed by digital subtraction angiography; meeting the surgical indications for flow-diverting devices, intracranial stents or coil embolization; patients who provide informed consent for this study and agree to follow-up imaging examinations. Exclusion Criteria: Coexistence of other cerebrovascular diseases; severe systemic disease with an expected survival time of less than 2 years; history of contrast medium allergy; patients refusing or unable to complete follow-up. 5. Chronic Subdural Hematoma Cohort Inclusion Criteria: Age \>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.