RecruitingNCT07754188

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

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

Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

274 participants

Start Date

Mar 19, 2026

Study Type

OBSERVATIONAL

Conditions

Unruptured Intracranial Aneurysm Wide-neck Aneurysm Intracranial Bifurcation Aneurysm

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Flow Diverter and a medical device called Stent-Assisted Coiling for people with intracranial bifurcation aneurysm, unruptured intracranial aneurysm, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFlow 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.

DEVICEStent-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.