Y-Stent-Assisted Coiling of Wide-Necked Intracranial Aneurysms With the Neuroform Atlas Stent System

Endovascular management of wide-necked bifurcation aneurysms poses a therapeutic challenge, as coiling often requires the use of multiple adjunctive stent constructs to achieve successful embolization without compromising parent vessel integrity. The Neuroform Atlas Stent System is a novel low-profile, intraluminal remodeling device. The study aims to investigate the safety and efficacy of Y-stent-assisted coiling configuration constructs using the next generation stent for aneurysm coil embolization.

Subjects undergoing Y-stent-assisted coiling in the ATLAS IDE (Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms with the Neuroform Atlas Stent System Investigational Device Exception) trial were identified for subgroup analysis. Enrollment in the trial was not stratified on the basis of the procedural stenting technique used. The primary efficacy end point was complete aneurysm occlusion (Raymond-Roy class 1) on 12-month angiography, in the absence of re-treatment or parent artery stenosis (>50%) at the target location. The primary safety end point was any major stroke or ipsilateral stroke or neurological death within 12 months. Adjudication of the primary end points was performed by an independent imaging core laboratory and the clinical events committee.

A total of 60 subjects were identified. The mean age was 59, and 28.3% were men. The median aneurysm size was 6.7 mm, with a median neck size of 4.3 mm. Frequently reported aneurysm locations included the basilar apex (56.7%), anterior communicating artery (20.0%), and middle cerebral artery bifurcation (11.7%). The composite primary efficacy end point was achieved in 81.1% of subjects. Overall, 1.7% of subjects experienced a primary safety endpoint of major ipsilateral stroke or neurological death.

In the ATLAS IDE aneurysm cohort premarket approval study, Y-stent-assisted coiling with Neuroform demonstrated high rates of complete aneurysm occlusion at 12 months, with low rates of morbidity.