Neuroform Atlas Stent System Study

The study is a prospective, multicenter, open-label, single arm trial designed to demonstrate the potential treatment of wide neck, intracranial, saccular aneurysms with the Next Generation Neuroform Stent System with any approved embolic coils currently on the market. The study will evaluate the percent occlusion of the treated target lesion on angiography in the absence of retreatment, or parent artery stenosis at the target location at 12 months. Subjects with documented wide neck, intracranial, saccular aneurysms arising from a parent artery may potentially benefit from stent assisted coiling, provided they meet the other eligibility criteria. Data collected through the 12-month follow-up visit are intended to support Premarket Approval (PMA) application to the Food and Drug Administration (FDA). Long-term follow-up data collected through 3 years postoperative are intended to support post-approval study (PAS) requirements.