The primary objective of this study is to demonstrate effectiveness and safety of the Neuroform Atlas Stent System for use with bare metal embolic coils.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
298
The Next Generation Neuroform Stent System is pre-loaded on a stent delivery wire and protected by a transfer sheath. An accessory pouch containing an optional stabilizer may be attached to the proximal end of the stent delivery wire to facilitate handling and stabilization.
Stroke or Death
Any major ipsilateral stroke or neurological death
Time frame: within 12 months of the index procedure
Aneurysm Occlusion of the Treated Target Lesion on 12 Month Angiography
Complete aneurysm occlusion (100% occlusion - Raymond Class 1) of the treated target lesion on 12 month angiography, in the absence of retreatment, or parent artery stenosis (\> 50%) at the target location.
Time frame: 12 month post index procedure
The Percent of Subjects Experiencing One or More Serious Adverse Events (SAEs) Through 12 Months
The percent of subjects experiencing one or more serious adverse events (SAEs) through 12 months including * New or worsening major ipsilateral stroke as measured by the National Institute of Health Stroke Scale (NIHSS) * Device-related SAEs * Subarachnoid hemorrhage (SAH) * Aneurysm rupture
Time frame: within 12 months post procedure
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