Pivotal trial of the Neuroform Atlas stent for treatment of posterior circulation aneurysms: one-year outcomes.
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Jankowitz Brian T, Jadhav Ashutosh P, Gross Bradley, Jovin Tudor G, Alhajeri Abdulnasser A, Fraser Justin F, Hanel Ricardo A, Sauvageau Eric, Aghaebrahim Amin, Frei Donald, Bellon Richard, Loy David, Puri Ajit S, Malek Adel M, Thomas Ajith, Toth Gabor, Lopes Demetrius Klee, Crowley R Webster, Arthur Adam S, Reavey-Cantwell John, Lin Eugene, Siddiqui Adnan H, Alexander Michael J, Khaldi Ahmad, Colby Geoffrey P, Caplan Justin M, Satti Sudhakar R, Turk Aquilla S, Spiotta Alejandro M, Klucznik Richard, Hallam Danial K, Kung David, Froehler Michael T, Callison R Charles, Kan Peter, Hetts Steven W, Zaidat Osama O
Аннотация
OBJECTIVE: To present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs.
METHODS: The ATLAS trial is a prospective, multicenter, single-arm, open-label study of unruptured, wide-necked, IAs treated with the Atlas stent and adjunctive coiling. This study reports the results of patients with posterior circulation IAs. The primary efficacy endpoint was complete aneurysm occlusion (Raymond-Roy (RR) class I) on 12-month angiography, in the absence of re-treatment or parent artery stenosis >50%. The primary safety endpoint was any major ipsilateral stroke or neurological death within 12 months. Adjudication of the primary endpoints was performed by an imaging core laboratory and a Clinical Events Committee.
RESULTS: The ATLAS trial enrolled and treated 116 patients at 25 medical centers with unruptured, wide-necked, posterior circulation IAs (mean age 60.2±10.5 years, 81.0% (94/116) female). Stents were placed in all patients with 100% technical success rate. A total of 95/116 (81.9%) patients had complete angiographic follow-up at 12 months, of whom 81 (85.3%) had complete aneurysm occlusion (RR class I). The primary effectiveness outcome was achieved in 76.7% (95% CI 67.0% to 86.5%) of patients. Overall, major ipsilateral stroke and secondary persistent neurological deficit occurred in 4.3% (5/116) and 1.7% (2/116) of patients, respectively.
CONCLUSIONS: In the ATLAS IDE posterior circulation cohort, the Neuroform Atlas Stent System with adjunctive coiling demonstrated high rates of technical and safety performance. Trial registration number https://clinicaltrials.gov/ct2/show/NCT02340585.