This prospective real-world cohort study aims to compare early postoperative complications between flow diverter treatment and stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms. A total of 274 patients from three centers in China will be enrolled and assigned to the flow diverter group or the stent-assisted coiling group according to the treatment received in routine clinical practice. The primary outcome is a composite of any stroke or all-cause death within 30 days after the procedure. The study will also collect demographic, clinical, laboratory, imaging, aneurysm morphological, procedural, and follow-up data to evaluate the safety of these two endovascular treatment strategies in a real-world setting.
Voluntarily provides written informed consent.
Aged 18 to 75 years.
Diagnosed by CTA, MRA, or DSA as having an unruptured, bifurcation, saccular, wide-neck intracranial aneurysm.
Able to understand the purpose of the study.
Patients with two or more multiple aneurysms, all of which require treatment within 1 year.
Patients with other cerebrovascular diseases such as arteriovenous malformation or moyamoya disease.
Patients with ruptured aneurysms or narrow-neck aneurysms.
Patients who experienced stroke, including cerebral hemorrhage or cerebral infarction, within the past 1 month.
Patients aged 18 to 75 years with unruptured, saccular, wide-neck intracranial bifurcation aneurysms diagnosed by CTA, MRA, or DSA who meet the clinical indications for endovascular treatment and are treated at participating centers. Eligible patients must provide written informed consent and will receive either flow diverter treatment or stent-assisted coiling according to the study protocol.
Cohort
Prospective
Flow Diverter
DeviceFlow diverter treatment will be performed according to routine clinical practice and relevant guidelines. A flow-diverting stent will be deployed to cover the aneurysm neck after angiographic evaluation and device sizing. Perioperative management and antiplatelet therapy will be performed according to the study protocol and clinical practice.
Stent-Assisted Coiling
DeviceStent-assisted coiling will be performed according to routine clinical practice and relevant guidelines. A stent will be deployed across the aneurysm neck, followed by coil embolization of the aneurysm. Perioperative management and antiplatelet therapy will be performed according to the study protocol and clinical practice.
Composite incidence of any stroke or all-cause death within 30 days after procedure
The primary outcome is the occurrence of any stroke or all-cause death within 30 days after the endovascular procedure. Stroke is defined as an acute onset of focal or global neurological dysfunction caused by vascular injury of the brain, spinal cord, or retina due to hemorrhage or infarction, with symptoms lasting 24 hours or longer.
Incidence of any stroke within 30 days after procedure
Incidence of any ischemic or hemorrhagic stroke within 30 days after the procedure.
Incidence of transient ischemic attack within 30 days after procedure
Incidence of transient ischemic attack within 30 days after the procedure. Transient ischemic attack is defined as a transient episode of focal neurological dysfunction caused by ischemia of the brain, spinal cord, or retina, with symptoms lasting less than 24 hours and without acute infarction.
Incidence of all-cause death within 30 days after procedure
Incidence of death from any cause within 30 days after the procedure.
Incidence of adverse events and serious adverse events within 30 days after procedure
Incidence of adverse events and serious adverse events recorded during the perioperative period and follow-up period.
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Nanfang Hospital, Southern Medical University
Lead sponsor
Zhujiang Hospital
Collaborator
Guangdong Province People's Hospital
Collaborator
