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 availability statement
Data may be obtained from a third party and are not publicly available.
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Collaborators ATLAS EU PMCF Investigators and coordinators: Ansgar Berlis, Christoph Maurer, Martin Seidler, Ilse Kummer, Sabine Hanisch, Gabriele Jochum-Pfeilsticker, Marius Hartmann, Steffen Reissberg, Sascha Schiffler, Nadja Rieckehr, Werner Weber, Annika Kowoll, Anushe Weber, Sebastian Fischer, Mara Postert, Peter Schramm, Thomas Eckey, André Kemmling, Alexander Neumann, Ramona Schramm, Alain Bonafé, Vincent Costalat, Carlos Riquelme, Pierre-Henri Lefevre, Grégory Gascou, Marinette Moynier, Emmanuel Houdart, Vittorio Civelli, Alexis Guédon, Jean-Pierre Saint-Maurice, Marc-Antoine Labeyrie, Alexandre Parpaleix, Baptiste Bonnet, Kamil Zelenak, Jana Zelenakova, Branislav Kolarovszki, Michel Piotin, Raphael Blanc, Stanislas Smajda, Jean-Philippe Desilles, Gabriele Ciccio, Robert Fahed, Hocine Redjem, Mylène Hamdani, Malek Ben Maacha, Lucia Lopes, Xavier Barreau, Gaultier Marnat, Florent Maire, Marine Premont, Laura Albizu, Jean-Christophe Gentric, Julien Ognard, Géraldine Viard, Ana Paula Narata, Vladimir Charron, Nicolas Charron
Contributors The last two authors contributed equally to the manuscript. All authors made substantial contributions to the conception and design, analysis, and interpretation of data; drafted or critically revised the article; and gave final approval of the version to be published.
Funding The ATLAS EU PMCF study (Evaluation of Safety and Performance of the Neuroform Atlas™ Stent System for Intracranial Aneurysm Treatment – Post Market Clinical Follow-up) was funded by Stryker Neurovascular (Fremont, California, United States).
Competing interests P-HL reports paid lectures with Stryker, Medtronic and Phenox outside the present study. PS reports speaker honoraria and travel support from Penumbra, Phenox and Stryker outside the present study. AK reports consulting and proctoring activities with Phenox, Penumbra, Stryker, Acandis outside the present study. XB reports service and related fees with Stryker outside this study and within past 3 years. Proctored or received service-related fees from MicroVention (Proctor). GM reports paid lectures with Microvention and Medtronic. MP reports shares in Basecamp Vascular. ABe reports a proctoring activity for Stryker outside this study and within past 3 years, proctored or received service-related fees from MicroVention (Proctor), Sequent Medical (Proctor), Phenox (lecture honorary, CEC), and Penumbra (lecture honorary). IW is speaker for Bayer, not related to the product. ABo is consultant for Stryker, Balt and Phenox. EH is the principal investigator of the present ATLAS EU study.
Provenance and peer review Not commissioned; externally peer reviewed.
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