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Pivotal trial of the Neuroform Atlas stent for treatment of posterior circulation aneurysms: one-year outcomes
- 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
- et al.
Published Web Location
https://doi.org/10.1136/neurintsurg-2020-017115Abstract
Background
Stent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results.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.Many UC-authored scholarly publications are freely available on this site because of the UC's open access policies. Let us know how this access is important for you.
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