Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorNanfang Hospital, Southern Medical University

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

274 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nanfang Hospital, Southern Medical University

Lead sponsor

Zhujiang Hospital

Collaborator

Guangdong Province People's Hospital

Collaborator