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Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms: A Prospective Real-World Cohort Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Guangdong Province People's Hospital
RECRUITING
Guangzhou
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
Zhujiang Hospital, Southern Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Huibin Kang Study Contact, MD
kanghuibindoctor@163.com
13520296286
Time Frame
Start Date: 2026-03-19
Estimated Completion Date: 2028-03-19
Participants
Target number of participants: 274
Treatments
Flow Diverter Group
Patients with unruptured wide-neck intracranial bifurcation aneurysms who receive flow diverter treatment in routine clinical practice.
Stent-Assisted Coiling Group
Patients with unruptured wide-neck intracranial bifurcation aneurysms who receive stent-assisted coiling in routine clinical practice.
Related Therapeutic Areas
Sponsors
Collaborators: Zhujiang Hospital, Guangdong Province People's Hospital
Leads: Nanfang Hospital, Southern Medical University

This content was sourced from clinicaltrials.gov