RT Journal Article
SR Electronic
T1 Multi-centric European post-market follow-up study of the Neuroform Atlas Stent System: primary results
JF Journal of NeuroInterventional Surgery
JO J NeuroIntervent Surg
FD BMJ Publishing Group Ltd.
SP neurintsurg-2021-017849
DO 10.1136/neurintsurg-2021-017849
A1 Pierre-Henri Lefevre
A1 Peter Schramm
A1 André Kemmling
A1 Xavier Barreau
A1 Gaultier Marnat
A1 Michel Piotin
A1 Ansgar Berlis
A1 Isabel Wanke
A1 Alain Bonafe
A1 Emmanuel Houdart
A1 ,
YR 2021
UL http://jnis.bmj.com/content/early/2021/09/02/neurintsurg-2021-017849.abstract
AB Background Few prospective series have described the safety and effectiveness of the Neuroform Atlas Stent System. We aimed to investigate the efficacy and safety of the device in patients treated for unruptured aneurysm.Methods ATLAS EU PMCF is a consecutive, prospective, multicentric study that included patients with unruptured saccular aneurysm of all sizes. Follow-up visits were scheduled at 3–6 months and 12–16 months with digital subtraction angiography (DSA) or MRI imaging follow-up as per the site standard of care. The primary efficacy endpoint was adequate aneurysm occlusion (Raymond Roy occlusion grade I and II) on 12 month angiography. The primary safety endpoint was any major stroke or ipsilateral stroke or neurological death within 12 months.Results Of the 106 patients consented, 105 were treated with at least one Neuroform Atlas stent. There was a failed implantation attempt in 1 patient, 85 patients received lateral stenting, and 19 patients received Y-stenting. Mean aneurysm neck size was 4.2 mm (range 1.9–33 mm). Adequate occlusion was observed in 95.1% immediately after the procedure and in 98.9% of cases at 1 year DSA follow-up. Overall, 1.0% (1/102; 95% CI 0.0% to 5.3%) of patients experienced a primary safety endpoint of major stroke. Three minor strokes resulted in a modified Rankin Scale score of 2.Conclusions In this multicentric, prospective study, stent-assisted coiling of medium size unruptured aneurysms with the Neuroform Atlas stent resulted in a favorable rate of satisfactory occlusion. In our findings, the use of the Y-stenting technique was associated with increased rates of procedural complications.Clinical trial registration https://clinicaltrials.gov/ct2/show/NCT02783339.Data may be obtained from a third party and are not publicly available.