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.
Signed informed consent form and agreement to comply with protocol requirements.
Need for treatment of another aneurysm in the affected territory of the target aneurysm using a different therapeutic modality during the study period.
Single group
Novel Flow Diverter Stent
DevicePatients 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.
Aneurysm Complete Occlusion Rate
Proportion of patients with complete occlusion of the target aneurysm at 1 year post-procedure, as assessed by the core imaging laboratory using the Raymond-Roy Occlusion Classification (Class I: complete obliteration).
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Beijing Tiantan Hospital
Lead sponsor
Huashan Hospital
Collaborator
Peking University International Hospital
Collaborator
Beijing Chao Yang Hospital
Collaborator
