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

September 14, 2026 updated by: Changhai Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cerebrovascular disease is the leading cause of disability and adult mortality in China,with a high overall incidence. The rapid advancement and widespread application of neurointerventional techniques have driven an annual increase in the volume of cerebrovascular interventional procedures. Consequently, various cerebrovascular diagnostic and therapeutic devices-including multiple domestically developed innovative devices-have gained market approval following pre-market clinical trials,thereby expanding clinical treatment options. However, pre-market studies are often limited by small sample sizes, restricted population representativeness, short observation periods, and highly controlled clinical environments, making it difficult to fully evaluate device performance in real-world clinical settings. Therefore, strengthening post-market device regulation and establishing a comprehensive post-market active surveillance system are critical. These measures are essential for the timely detection and management of clinical risks,ensuring patient safety, accumulating real-world data (RWD), and supporting the optimization of health policies and healthcare reimbursement decisions. China has long prioritized the post-market surveillance of medical devices. Since initiating a pilot program for medical device adverse event (MDAE) monitoring in 2002, China successively promulgated the Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events (Trial) in 2008 and the revised Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events in 2018 to strengthen device surveillance. Furthermore, the newly revised Regulations on the Supervision and Administration of Medical Devices (State Council Decree No.739 of the People's Republic of China), promulgated in 2021, emphasize full-lifecycle, full-process and full-chain oversight of medical devices. Throughout this progression, China has established the Medical Device Adverse Event Reporting and Management System, anchored by provincial MDAE monitoring centers. This system enables medical institutions and manufacturers that identify adverse events to submit reports, increasing the volume of adverse event submissions and improving risk monitoring and control capacity. However, it is notable that China's existing post-market regulatory framework for medical devices still faces a significant challenge: the lack of an active surveillance system. The current reporting system, which designates medical device registrants as the primary responsible entities, is voluntary rather than mandatory. This inevitably leads to inherent flaws such as low reporting rates, high misreporting rates, the inability to calculate true incidence rates, and delayed signal detection. Consequently, the real-world safety, effectiveness, and health economics of medical devices cannot be comprehensively evaluated, posing potential risks to public health safety and the efficient utilization of healthcare resources. Therefore, it is imperative to transition from a passive surveillance model to an active surveillance paradigm characterized by proactive data collection and active outcome analysis. Although active surveillance takes various forms, conducting real-world active surveillance based on healthcare data has become a prevailing trend. This is driven by the enhanced integration and application of healthcare data, alongside continuous advancements in analytical techniques. For instance, in 2012, the U.S. Food and Drug Administration (FDA) initiated the Medical Device Epidemiology Network (MDEpiNet)-a multi-stakeholder collaborative platform involving healthcare institutions, academic organizations, device manufacturers, and patient advocacy groups. This initiative aims to conduct surveillance research by sharing resources across network members and integrating RWD, including electronic health records (EHR), cohort studies, and healthcare claims data. In recent years, China has initiated pilot programs for active post-market surveillance of medical devices (i.e., the medical device vigilance system) in regions such as Jiangsu, yielding preliminary results. Overall, however, the implementation of real-world evaluation still faces significant challenges: 1. Lack of a unified national surveillance system: Inefficient cross-hospital collaboration hinders standardized data integration and creates isolated information silos. 2. Absence of a multi-center collaborative network: The surveillance framework is solely regulator-led, leaving healthcare institutions (core data providers) with insufficient incentives for active data submission and early risk alerting. 3. Deficient long-term follow-up workflows: Incomplete longitudinal follow-up data limits the availability of health economic evidence to support healthcare policy design. China has unique national conditions: a vast territory, large population, heterogeneous regional epidemiological profiles, and unbalanced socioeconomic and healthcare resources. Combined with the broad clinical adoption of post-market cerebrovascular devices (domestic innovative devices in particular) and the massive volume of real-world data they generate, the above challenges will be further exacerbated when rolling out nationwide active surveillance. Therefore, the successful implementation of active medical device surveillance tailored to China's context relies on several key strategies: First, coordinating inter-hospital collaboration through departments with core advantages in cross-sector coordination to construct a national system and achieve data harmonization across medical institutions.Second, empowering medical institutions as the primary executing entities of active surveillance by leveraging specialized academic influence to build collaborative networks and research-sharing mechanisms, thereby incentivizing institutional participation.Third, establishing research cohorts with standardized disease follow-up protocols to acquire robust long-term follow-up data for comprehensive longitudinal and health economic evaluations.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • Percutaneous Transluminal Angioplasty
  • Intracranial Arterial Stenting
  • Percutaneous Transluminal Angioplasty and Stenting
  • Extracranial Arterial Angioplasty and Stenting
  • Endovascular Embolization of Intracranial Aneurysm
  • Coil Embolization
  • Flow-Diverter Implantation
  • Middle Meningeal Artery Embolization for Chronic Subdural Hematoma
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Outcome
Time Frame: From enrollment to the end of treatment at 90 days
Functional Outcome: Modified Rankin Scale (mRS) score at 90 days.
From enrollment to the end of treatment at 90 days
Successful Vascular Recanalization Rate
Time Frame: From enrollment to the end of treatment at 90 days
Successful Vascular Recanalization Rate: eTICI grade of target vessel reperfusion after thrombectomy.
From enrollment to the end of treatment at 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

September 14, 2026

First Submitted That Met QC Criteria

September 14, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PostMkt AS&HEE for Cerebrovasc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participant privacy and data-protection requirements. IPD contains identifiable personal information, and sharing would risk breach of patient confidentiality.

Incomplete or ongoing analysis of the dataset. The investigators have not finished planned analyses and publications.

Restrictions from informed consent. Study participants were not consented to release their raw individual-level data.

Intellectual property and sponsor-related constraints. Data ownership limits public distribution of IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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