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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Endovascular Treatment for Acute Ischemic Stroke
Procedure/SurgeryMiddle 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
Trial outcomes
Primary outcomes
Functional Outcome
Functional Outcome: Modified Rankin Scale (mRS) score at 90 days.
Successful Vascular Recanalization Rate
Successful Vascular Recanalization Rate: eTICI grade of target vessel reperfusion after thrombectomy.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: