Pivotal trial of the Neuroform Atlas stent for treatment of posterior circulation aneurysms: one-year outcomes

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: 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://ichgcp.net/clinical-trials-registry/NCT02340585.

Keywords: aneurysm; coil; stent.

Conflict of interest statement

Competing interests: BTJ: consultant for Stryker and a consultant/proctor for Medtronic. OOZ: research grant from Stryker, Medtronic, Cerenovus, Penumbra, and Genentech; consultant and speaker for Cerenovus, Stryker, Penumbra, and Medtronic; has ownership interest in Galaxy Therapeutics LLC; and serves on the endovascular committee as co-chair for National Institutes of Health StrokeNet Consortium and has served as an expert witness. SWH: Core Laboratory Services for Stryker and MicroVention Terumo (money paid to UCSF, over $5k); consulting for Microvention Terumo (money paid to SWH, under $5k). APJ: reports no conflicts. BG: consultant for Medtronic and Microvention. TGJ: consultant at Cerenovus (steering committee/DSMB–modest), Stryker Neurovascular (PI DAWN (DWI or CTP Assessment with Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention With Trevo)-unpaid); holds Stock at Anaconda, Blockade Medical, Route 92, Corindus, FreeOx Biotech, Viz.ai, Silk Road. JFF: equity - Fawkes Biotechnology, Cerelux, LLC; consultant: Medtronic, Penumbra, Stream Biomedical. RAH: research Grant: Medtronic, Stryker, Microvention, Cerenovus; consultant: Stryker, Medtronic, Cerenovus, Microvention; stockholder: Neurvana, Elum, EndoStream, Three Rivers Medical Inc, Rist, Cerebrotech, InNeuroCo; Scientific Advisor: MIVI, Elum, Three Rivers Medical Inc, Shape Medical. ES: reports a speakers’ agreement with Stryker. AA: reports no conflicts. DF: consultant/speakers bureau for Stryker; consultant/speakers bureau for Siemens, Penumbra, Philips, Genentech, Viz.AI; Scientific Advisory Board for Shape Memory Medical. AMM: consulting fees/honoraria: Microvention-Terumo Inc., Stryker Inc; major stock shareholder/equity: Cerevasc LLC; ownership/founder: Cerevasc LLC; intellectual property rights: Cerevasc LLC, Tufts Medical Center. AT: SCENT data safety monitoring board, funds paid to the institution. GT: consultant to Dynamed, Medtronic, and Microvention. DKL: consultant for Stryker Neurovascular. MJA: consultant for Stryker Neurovascular. AHS: financial Interest/investor/stock options/ownership for Amnis Therapeutics, Boston Scientific (for acquisition of Claret Medical), Buffalo Technology Partners, Inc., Cognition Medical, Endostream Medical, Ltd, Imperative Care, International Medical Distribution Partners, Q’Apel Medical, Inc, Rebound Therapeutics Corp., Rist Neurovascular, Inc, Serenity Medical, Inc, Silk Road Medical, Spinnaker Medical, Inc, Synchron; consultant/advisory board for Amnis Therapeutics, Boston Scientific, Cerenovus, Endostream Medical, Ltd, Imperative Care, Integra LifeSciences Corp., Medtronic, MicroVention, Penumbra, Q’Apel Medical, Inc., Rapid Medical, Rebound Therapeutics Corp, Serenity Medical, Inc, Silk Road Medical, Stryker, W.L. Gore & Associates National PI/Steering Committees: Cerenovus LARGE Trial and ARISE II Trial, mal Medtronic SWIFT PRIME and SWIFT DIRECT Trials; MicroVention FRED Trial and CONFIDENCE Study; MUSC POSITIVE Trial; Penumbra 3D Separator Trial, COMPASS Trial, INVEST Trial. PK: consultant for Stryker and Cerenovus; stockholder of InNeuroCo. MTF: grant funding from NIH, Medtronic, Microvention, Stryker, and Genentech; consultant for Medtronic, Stryker, Balt USA, Viz.ai, Genentech, Cerenovus, Corindus, and EndoPhys. AMS: research support from Stryker, Medtronic, and Penumbra; consulting for Stryker, Terumo, Penumbra, and Siemens. ASA: consultant for Johnson and Johnson, Medtronic, Microvention, Penumbra, Scientia, Siemens, Stryker; research support from Balt, Cerenovus, Medtronic, Microvention, Penumbra, Siemens, and Stryker; shareholder in Bendit, Cerebrotech, Endostream, Magneto, Marblehead, Mentice, Neurogami, Serenity, Synchron, Triad Medical. RWC: proctor for Medtronic and Cerenovus. SRS: consultant for Balt, Cerenovus, Cordis, Medtronic, Microvention, Terumo, Stryker. GPC: consultant and proctor for Stryker, MicroVention, and Medtronic. JMC: reports no disclosures. AAA: reports no disclosures. JRC: reports no disclosures. AK: reports no disclosures. RCC: consulting for Stryker. EL: reports no disclosures. AST: reports no disclosures. DL: reports no disclosures. DK: reports no disclosures. DKH: reports no disclosures. ASP: reports no disclosures. No CEC/DSMB members are from participating sites of the study. UCSF is not a participating site. RB and RK delcare none.

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