NCT07828379Not yet recruiting
Post-Market Active Surveillance and Health Economic Evaluation of Cerebrovascular Diagnostic and Therapeutic Devices
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 14 Sept 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- Changhai Hospital
- Diseases
- Stroke
- NCT number
- NCT07828379
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 1 Sept 2026 to the primary completion date, 1 Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another clinical trial of drugs or devices within the past 3 months or ongoing participation in such trials.
- Contraindications to stenting; participation in another clinical trial of drugs or devices within the past 6 months or ongoing participation in such trials.
- 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.
Other illness
- 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.
- 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.
Other
- Intracranial Arterial Stenosis Cohort
- Extracranial Arterial Stenosis Cohort
- Intracranial Aneurysm Cohort
- Chronic Subdural Hematoma Cohort
Who the study is looking for
- 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.
- 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.
- 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.
- 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.
- 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.
Criteria the registry did not label
- Acute Ischemic Stroke Cohort
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.