China builds national watchdog for brain blood vessel devices
NCT ID NCT07828379
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers at Changhai Hospital are setting up a nationwide system to monitor how well devices and procedures for cerebrovascular conditions perform after they reach the market. The study plans to enroll about 2,000 adults with acute ischemic stroke, narrowed brain or neck arteries, brain aneurysms, or chronic subdural hematoma. By following patients and collecting data across many hospitals, the team aims to measure safety, effectiveness, and cost, which could help regulators make better decisions about these treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cerebrovascular devices and endovascular procedures, including clot removal, artery stenting, aneurysm coiling, flow diverters, and middle meningeal artery embolization
- What this could lead to
- If the surveillance network works, it could give doctors and regulators real-world evidence on which stroke and aneurysm devices help patients most and at what cost.
- What could go wrong
- This is an observational study, so it cannot prove cause and effect. Results may be limited by how completely patients are followed and by differences between hospitals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 2,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
All patients with acute ischemic stroke, intracranial arterial stenosis, extracranial arterial stenosis, intracranial aneurysm and chronic subdural hematoma who receive cerebrovascular interventional therapy
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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