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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorChanghai Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Acute Ischemic Stroke Cohort

Disqualifiers

Intracranial Arterial Stenosis Cohort

Extracranial Arterial Stenosis Cohort

Intracranial Aneurysm Cohort

Chronic Subdural Hematoma Cohort

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Endovascular Treatment for Acute Ischemic Stroke

    Procedure/Surgery

    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.

Treatment groups

2,000 Participants
are divided into 5 treatment groups
Group A: Acute Ischemic Stroke1 intervention
Group B: Intracranial Arterial Stenosis ICAS0 interventions
Group C: Extracranial Arterial Stenosis ECAS0 interventions
Group D: Intracranial Aneurysm IA0 interventions
Group E: Chronic Subdural Hematoma CSDH0 interventions

Trial outcomes

Primary outcomes

1

Functional Outcome

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

Time frame
From enrollment to the end of treatment at 90 days
2

Successful Vascular Recanalization Rate

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

Time frame
From enrollment to the end of treatment at 90 days

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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