RecruitingNot ApplicableNCT07821957

A Multicenter Prospective Study of New Flow Diverter Stent on the Treatment of Intracranial Aneurysms in China

Sponsor

Beijing Tiantan Hospital

Enrollment

280 participants

Start Date

Jan 6, 2026

Study Type

INTERVENTIONAL

Conditions

Intracranial Aneurysm

Summary

Intracranial aneurysm, as a common cerebrovascular disease, has a variety of treatment methods, including surgical treatment and endovascular treatment. Among these treatment methods, flow diverters have attracted much attention due to their unique therapeutic principles. Flow diverters help promote thrombus formation within the aneurysm by altering the direction and dynamics of blood flow, thereby achieving the purpose of treatment. 1-5 Flow diverters such as the Pipeline™ device have been proven to be safe and effective for the treatment of intracranial aneurysms and have gradually been recognized as the preferred device for the management of intracranial aneurysms.

Eligibility

Min Age: 22 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Novel Flow Diverter Stent for people with intracranial aneurysm. The study is currently recruiting participants at 1 location. People eligible for this study include aged 22 Years to 80 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

DEVICENovel Flow Diverter Stent

Patients with intracranial wide-neck aneurysms undergo implantation of new generation flow diverter stents (e.g., Pipeline Shield, Lattice, etc.) per IFU and local practice. Stent reconstructs parent artery, diverts flow, promoting aneurysm thrombosis. Concomitant antiplatelet therapy (DAPT: aspirin + clopidogrel/ticagrelor) given per guidelines, continued ≥3-6 months post-procedure. This is a prospective, multicenter, single-arm, real-world study in China (≈15 sites, N=280). Follow-up: 30d, 6m, 1y, then annually to 4y post-procedure, including clinical (mRS) and imaging (DSA/CTA) assessments.