Pivotal trial of the Neuroform Atlas stent for treatment of posterior circulation aneurysms: one-year outcomes
Year: 2021
Type: article
Study design: Clinical Trial
Abstract: 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: https://clinicaltrials.gov/ct2/show/NCT02340585.
Authors: Brian T Jankowitz, Ashutosh P Jadhav, Bradley Gross, Tudor G Jovin, Abdulnasser A Alhajeri, Justin F Fraser, Ricardo A Hanel, Eric Sauvageau, Amin Aghaebrahim, Donald Frei, Richard Bellon, David Loy, Ajit S Puri, Adel M Malek, Ajith Thomas, Gabor Toth, Demetrius Klee Lopes, R Webster Crowley, Adam S Arthur, John Reavey-Cantwell, Eugene Lin, Adnan H Siddiqui, Michael J Alexander, Ahmad Khaldi, Geoffrey P Colby, Justin M Caplan, Sudhakar R Satti, Aquilla S Turk, Alejandro M Spiotta, Richard Klucznik, Danial K Hallam, David Kung, Michael T Froehler, R Charles Callison, Peter Kan, Steven W Hetts, Osama O Zaidat
Institutions: Cooper University Hospital, Barrow Neurological Institute, University of Pittsburgh Medical Center, University of Kentucky, Baptist Medical Center Jacksonville, Neurological Institute of Thailand, Radiology Associates, University of Virginia Hospital, University of Virginia Medical Center, University of Massachusetts Chan Medical School, Tufts Medical Center, Beth Israel Deaconess Medical Center, Cleveland Clinic, Advocate Health Care, Rush University, University of Tennessee Health Science Center, Semmes Murphey Foundation, Virginia Commonwealth University, Mercy St. Vincent Medical Center, Mercy Health, University at Buffalo, State University of New York, Cedars-Sinai Medical Center, WellStar Health System, University of California, Los Angeles, Johns Hopkins University, Johns Hopkins Medicine, Centro de Ciencias Humanas y Sociales, Prisma Health, Prisma, Medical University of South Carolina, Houston Methodist, University of Washington, University of Pennsylvania, Vanderbilt University, Baylor College of Medicine, University of California, San Francisco
Language: English
Subfield: Clinical Neurology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W3136757196