About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Flow Diverter
- Stent-Assisted Coiling
Treatment groups
Sponsors and collaborators
Nanfang Hospital, Southern Medical University
Lead sponsor
Zhujiang Hospital
Collaborator
Guangdong Province People's Hospital
Collaborator