Multi-centric European post-market follow-up study of the Neuroform Atlas Stent System: primary results

Abstract

BackgroundFew 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.MethodsATLAS 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.ResultsOf 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.ConclusionsIn 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 registrationhttps://clinicaltrials.gov/ct2/show/NCT02783339.

Application of the Neuroform Atlas Stent in Intracranial Aneurysms: Current Status

“…The third was a multicentric European post-market follow-up study of the NAS-assisted coiling of anterior (90.5%) and posterior (9.5%) circulation aneurysms; in all, 105 patients were enrolled. The technical success rate was 94.7%, the mean aneurysm size was 5.8 ± 2.5 mm, and adequate occlusion was found in 98.9% of patients on follow-up (10). In these trials, the prognosis after EVT was satisfactory, with adequate occlusion in approximately 95% of patients (9)(10)(11).…”

“…The technical success rate was 94.7%, the mean aneurysm size was 5.8 ± 2.5 mm, and adequate occlusion was found in 98.9% of patients on follow-up (10). In these trials, the prognosis after EVT was satisfactory, with adequate occlusion in approximately 95% of patients (9)(10)(11).…”

“…Clinical trials of the NAS have been performed with the aim of using it to assist in the coiling of wide-necked intracranial aneurysms, which were defined by a neck ≥4 mm and a dome-to-neck ratio <2 (5,6,(9)(10)(11). Recently, three prospective trials (2020-2022) with large series have been performed (9)(10)(11).…”

“…Currently, intracranial aneurysms are categorized as small (<7 mm), medium (7-12 mm), large (>12-25 mm) or giant (>25 mm) (13). In the three trials mentioned above, most aneurysms in the anterior and posterior circulation were small and medium, respectively, indicating that NAS-assisted coiling is effective for small and medium aneurysms (9)(10)(11).…”

Enterprise 2 Stent-Assisted Embolization of Paraclinoid Aneurysms: A Single Center Preliminary Study

“…The follow-up outcome was assessed using the mRS score, the 0–3 score was regarded as a good outcome, and the 4–5 score was regarded as poor outcome. 15 Aneurysms that reappeared three months following complete occlusion or residual aneurysms increasing after incomplete occlusion were regarded as recurrent. 16 The line’s midpoint connecting the parent artery’s long diameter and the blood vessel’s turning point was defined as the inner bending radius, and the gap between the inner/outer vessel wall and the stent was measured concerning incomplete stent apposition.…”