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Clinical Trial
. 2024 Oct 14;16(11):1125-1130.
doi: 10.1136/jnis-2023-020591.

Anterior circulation location-specific results for stent-assisted coiling - carotid versus distal aneurysms: 1-year outcomes from the Neuroform Atlas Stent Pivotal Trial

Ricardo A Hanel  1 , Gustavo M Cortez  2 , Brian T Jankowitz  3 , Eric Sauvageau  2 , Amin Aghaebrahim  2 , Eugene Lin  4 , Ashutosh P Jadhav  5   6 , Bradley Gross  7 , Ahmad Khaldi  8 , Rishi Gupta  8 , Donald Frei  9 , David Loy  9 , Lori Lyn Price  10 , Steven W Hetts  11 , Osama O Zaidat  4 ; ATLAS Investigators
Collaborators, Affiliations
Clinical Trial

Anterior circulation location-specific results for stent-assisted coiling - carotid versus distal aneurysms: 1-year outcomes from the Neuroform Atlas Stent Pivotal Trial

Ricardo A Hanel et al. J Neurointerv Surg. .

Abstract

Background: The Neuroform Atlas Stent System is an established treatment modality for unruptured anterior and posterior circulation intracranial aneurysms. Location-specific results are needed to guide treatment decision-making. However, it is unclear whether there are differences in safety and efficacy outcomes between carotid and more distal anterior circulation aneurysms.

Methods: The ATLAS IDE trial was a prospective, multicenter, single-arm, open-label interventional study that evaluated the safety and efficacy of the Neuroform Atlas Stent System. We compared differences in efficacy and safety outcomes of proximal internal carotid artery (ICA) versus distal and bifurcation anterior circulation aneurysms.

Results: Of 182 cases, there were 70 aneurysms in the ICA and 112 in the distal anterior circulation (including ICA terminus/bifurcation). There were no significant differences in the primary efficacy endpoint (85.5% vs 83.9%, p=0.78) and complete aneurysm occlusion rates (88.7% vs 87.9%, p=0.78) between proximal ICA aneurysms and distal aneurysms, respectively. Complications were more often encountered in distal and bifurcation aneurysms, but the overall rate of major safety events was low and comparable between the two groups (1.4% vs 6.3%, p=0.14). Recanalization and retreatment rates were also similar between the groups.

Conclusion: The results of this study suggest that the Neuroform Atlas Stent System is a safe and efficacious treatment modality for unruptured anterior circulation intracranial aneurysms, regardless of aneurysm location.

Trial registration number: NCT02340585.

Keywords: Aneurysm; Coil; Device; Intervention; Stent.

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Conflict of interest statement

Competing interests: RAH is a consultant for Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, Rapid Medical and Q’Apel, Imperative Care, Phenox, and Rapid Medical. He is on the advisory board for MiVI, eLum, Three Rivers, Shape Medical, and Corindus. He is in receipt of unrestricted research grants from the National Institutes of Health (NIH), Interline Endowment, Microvention, Stryker, CNX, and Balt. He is an investor/stockholder for InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc, Scientia, RisT, BlinkTBI, and Corindus. BTJ is a consultant for Stryker and a consultant/proctor for Medtronic. ES reports a speaker’s agreement with Stryker. BG is a consultant for Medtronic, Microvention, and Stryker. RGG is a consultant and receives personal fees from Cerenovus. DF reports consultant/speakers bureau for Stryker, Siemens, Penumbra, and Scientia; and serves on the SNIS board of directors. LLP is a Principal Biostatistician employed at Stryker Neurovascular and holds stock in Stryker. SWH reports core lab services for Stryker, Route 92; is an Imperative Care consultant; is a stockholder for Filtro and ThrombX; and serves on the SNIS board of directors. OOZ reports research grants from Stryker, Medtronic, Cerenovus, Penumbra, and Genentech; he is a consultant and speaker for Cerenovus, Stryker, Penumbra, and Medtronic; data safety monitoring board for Premier; has an ownership interest in Galaxy Therapeutics Inc.; and serves on SVIN committees. The other authors report no conflicts of interest.

Figures

Figure 1
Figure 1. Patient flow diagram and aneurysm location distribution from ATLAS IDE trial subanalysis groups. DSA, digital subtraction angiography; ICA, internal carotid artery; mITT, modified intent-to-treat.
See this image and copyright information in PMC

References

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