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

NCT07828379 | Not Yet Recruiting

• 1 other identifier: PostMkt AS&HEE for Cerebrovasc
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Functional Outcome

  Functional Outcome: Modified Rankin Scale (mRS) score at 90 days.

  From enrollment to the end of treatment at 90 days

• Successful Vascular Recanalization Rate

  Successful Vascular Recanalization Rate: eTICI grade of target vessel reperfusion after thrombectomy.

  From enrollment to the end of treatment at 90 days

Study Arms (5)

Acute Ischemic Stroke

In the acute large-vessel occlusion stroke cohort, full-life-cycle surveillance will be conducted for thrombectomy stents, aspiration catheters and other devices. This meets the guideline requirement that "the surveillance platform should include hospitals representative of regions, diseases and device usage". Data generated from the use of the above-mentioned devices will be analyzed to implement active surveillance.

Procedure: Endovascular Treatment for Acute Ischemic Stroke

Intracranial Arterial Stenosis ICAS

In the intracranial arterial stenosis cohort, full-life-cycle surveillance will be performed for balloons, intracranial stents and other devices. This satisfies the guideline requirement that "the surveillance platform should include hospitals representative of regions, diseases and device usage". Data from the use of the above-mentioned devices will be analyzed to implement active surveillance.

Extracranial Arterial Stenosis ECAS

In the extracranial arterial stenosis cohort, full-life-cycle surveillance will be conducted for optical coherence tomography (OCT) scanners, vertebral artery orifice drug-eluting stents and other related devices. This complies with the guideline requirement that the surveillance platform covers hospitals representative of regional distribution, disease types and device application scenarios. Data related to the clinical use of the above devices will be analyzed to complete active surveillance.

Intracranial Aneurysm IA

In the intracranial aneurysm cohort, full-life-cycle surveillance will be conducted for flow-diverter devices, adjunctive embolization stents and other interventional devices. This complies with the guideline requirement that "the surveillance platform should include hospitals representative of regions, diseases and device usage". Data generated from the use of the above-mentioned devices will be analyzed to implement active surveillance.

Chronic Subdural Hematoma CSDH

In the chronic subdural hematoma cohort, full-life-cycle surveillance will be conducted for middle meningeal artery embolization materials and related devices. This complies with the guideline requirement that "the surveillance platform should include hospitals representative of regions, diseases and device usage". Data generated from the use of the above-mentioned devices will be analyzed to implement active surveillance.

Interventions

Endovascular Treatment for Acute Ischemic Stroke PROCEDURE

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.

Also known as: Intracranial Arterial Stenting, Percutaneous Transluminal Angioplasty and Stenting, Percutaneous Transluminal Angioplasty, Extracranial Arterial Angioplasty and Stenting, Endovascular Embolization of Intracranial Aneurysm, Coil Embolization, Flow-Diverter Implantation, Middle Meningeal Artery Embolization for Chronic Subdural Hematoma

Acute Ischemic Stroke

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with acute ischemic stroke, intracranial arterial stenosis, extracranial arterial stenosis, intracranial aneurysm and chronic subdural hematoma who receive cerebrovascular interventional therapy

You may qualify if:

• 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.

You may not qualify if:

• Participation in another clinical trial of drugs or devices within the past 3 months or ongoing participation in such trials.
• Intracranial Arterial Stenosis Cohort
• 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.
• Contraindications to stenting; participation in another clinical trial of drugs or devices within the past 6 months or ongoing participation in such trials.
• Extracranial Arterial Stenosis Cohort
• 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.
• 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.
• Intracranial Aneurysm Cohort
• 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.
• 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.
• Chronic Subdural Hematoma Cohort
• 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.
• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Aneurysm; Hematoma, Subdural, Chronic

Interventions

Angioplasty; Stents

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Craniocerebral Trauma; Trauma, Nervous System; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Prostheses and Implants; Equipment and Supplies

Central Study Contacts

Yu Zhou

CONTACT

860213116178; yzhou_2011@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share