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RECRUITING
NCT07754188

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

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

274

Start Date

2026-03-19

Completion Date

2028-03-19

Last Updated

2026-08-10

Healthy Volunteers

No

Interventions

DEVICE

Flow Diverter

Flow 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.

DEVICE

Stent-Assisted Coiling

Stent-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.

Locations (3)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Guangdong Province People's Hospital

Guangzhou, China

Zhujiang Hospital, Southern Medical University

Guangzhou, China