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1. Y‐Stent–Assisted Coiling of Wide‐Necked Intracranial Aneurysms With the Neuroform Atlas Stent System

Author

Ashutosh P. Jadhav, Shashvat M. Desai, Tudor G. Jovin, Ricardo A. Hanel, Eric A. Sauvageau, Amin Aghaebrahim, Eugene Lin, Ahmad Khaldi, Rishi G. Gupta, Andrew K. Johnson, Donald Frei, David Loy, Adel Malek, Gabor Toth, Adnan Siddiqui, John Reavey‐Cantwell, Ajith Thomas, Steven W. Hetts, Osama O. Zaidat, and Brian T. Jankowitz

Subjects
aneurysm, bifurcated aneurysm, coiling, hemorrhagic stroke, wide‐neck, Y‐stent, Neurology. Diseases of the nervous system, RC346-429, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background Endovascular management of wide‐necked bifurcation aneurysms poses a therapeutic challenge, as coiling often requires the use of multiple adjunctive stent constructs to achieve successful embolization without compromising parent vessel integrity. The Neuroform Atlas Stent System is a novel low‐profile, intraluminal remodeling device. The study aims to investigate the safety and efficacy of Y‐stent–assisted coiling configuration constructs using the next generation stent for aneurysm coil embolization. Methods Subjects undergoing Y‐stent–assisted coiling in the ATLAS IDE (Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms with the Neuroform Atlas Stent System Investigational Device Exception) trial were identified for subgroup analysis. Enrollment in the trial was not stratified on the basis of the procedural stenting technique used. The primary efficacy end point was complete aneurysm occlusion (Raymond–Roy class 1) on 12‐month angiography, in the absence of re‐treatment or parent artery stenosis (>50%) at the target location. The primary safety end point was any major stroke or ipsilateral stroke or neurological death within 12 months. Adjudication of the primary end points was performed by an independent imaging core laboratory and the clinical events committee. Results A total of 60 subjects were identified. The mean age was 59, and 28.3% were men. The median aneurysm size was 6.7 mm, with a median neck size of 4.3 mm. Frequently reported aneurysm locations included the basilar apex (56.7%), anterior communicating artery (20.0%), and middle cerebral artery bifurcation (11.7%). The composite primary efficacy end point was achieved in 81.1% of subjects. Overall, 1.7% of subjects experienced a primary safety endpoint of major ipsilateral stroke or neurological death. Conclusion In the ATLAS IDE aneurysm cohort premarket approval study, Y‐stent–assisted coiling with Neuroform demonstrated high rates of complete aneurysm occlusion at 12 months, with low rates of morbidity.

Published
2023
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2. Pivotal Trial of the Neuroform Atlas Stent for Treatment of Anterior Circulation Aneurysms: One-Year Outcomes

Author

Osama O. Zaidat, Ricardo A. Hanel, Eric A. Sauvageau, Amin Aghaebrahim, Eugene Lin, Ashutosh P. Jadhav, Tudor G. Jovin, Ahmad Khaldi, Rishi G. Gupta, Andrew Johnson, Donald Frei, David Loy, Adel Malek, Gabor Toth, Adnan Siddiqui, John Reavey-Cantwell, Ajith Thomas, Steven W. Hetts, Brian T. Jankowitz, Bradley Gross, Andrew Ducruet, David Panczkowski, Hazem Shoirah, Alhamza Al-Bayati, Greg Weiner, Cynthia Kenmuir, Prasanna Tadi, Gregory Walker, K. Johnson, Don Frei, Richard Bellon, Benjamin Atchie, Ian Kaminsky, Dan Huddle, Mark Bain, Peter Rasmussen, M. Shazam Hussain, Nina Moore, Thomas Masaryk, Mohamed Elgabaly, Russell Cerejo, Julian Hardman, Seby John, Andrew Bauer, Jenny Peih-Chir Tsai, Elad Levy, Kenneth Snyder, Jason Davies, Christopher Ogilvy, Dennis Rivet, Michael Alexander, Franklin Moser, Marcel Maya, Michael Schiraldi, Paula Eboli, Justin Caplan, Bowen Jiang, Matthew Bender, Geoffrey Colby, Sudhakar Satti, Thinesh Sivapatham, David Kung, Bryan Pukenas, Robert Hurst, Michelle J. Smith, Ajit Puri, Francesco Massari, David Rex, Justin Fraser, Stephen Grupke, Abdulnasser Alhajeri, Richard Klucznik, Orlando Diaz, Gavin Britz, Yi Zhan, Alejandro Spiotta, Jonathan Lena, Aquilla Turk, Mohamad Chaudry, Kyle Fargen, Raymond Turner, Peter Kan, Edward Duckworth, Muhammad Asif Taqi, Samuel Hou, Adam S. Arthur, Lucas Elijovich, Daniel Hoit, Christopher Nickele, Jay Vachhani, Vinodh Thomas Doss, Richard Crowley, Demetrius Lopes, Michael Chen, Danial Hallam, Basavaraj Ghodke, Louis Kim, Richard Callison, Amer Alshekhlee, Sushant Kale, Michael Froehler, Matt Fusco, and Rohan Chitale

Subjects
Adult, Male, medicine.medical_specialty, medicine.medical_treatment, Original Contributions, 030218 nuclear medicine & medical imaging, 03 medical and health sciences, Clinical and Population Sciences, 0302 clinical medicine, Atlas (anatomy), medicine.artery, medicine, Humans, angiography, Coil embolization, Aged, Advanced and Specialized Nursing, middle cerebral artery, medicine.diagnostic_test, business.industry, Endovascular Procedures, Stent, Intracranial Aneurysm, Middle Aged, Embolization, Therapeutic, medicine.anatomical_structure, Treatment Outcome, Angiography, Middle cerebral artery, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Female, Stents, stent, Neurology (clinical), Radiology, Cardiology and Cardiovascular Medicine, business, retreatment, 030217 neurology & neurosurgery
Abstract

Supplemental Digital Content is available in the text., Background and Purpose: Stent-assisted coil embolization using the new generation Neuroform Atlas Stent System has shown promising safety and efficacy. The primary study results of the anterior circulation aneurysm cohort of the treatment of wide-neck, saccular, intracranial, aneurysms with the Neuroform Atlas Stent System (ATLAS trial [Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms With the Neuroform Atlas Stent System]) are presented. Methods: ATLAS IDE trial (Investigational Device Exemption) is a prospective, multicenter, single-arm, open-label study of wide-neck (neck ≥4 mm or dome-to-neck ratio 50%) at the target location. The primary safety end point was any major stroke or ipsilateral stroke or neurological death within 12 months. Adjudication of the primary end points was performed by an independent Imaging Core Laboratory and the Clinical Events Committee. Results: A total of 182 patients with wide-neck anterior circulation aneurysms at 25 US centers were enrolled. The mean age was 60.3±11.4 years, 73.1% (133/182) women, and 80.8% (147/182) white. Mean aneurysm size was 6.1±2.2 mm, mean neck width was 4.1±1.2 mm, and mean dome-to-neck ratio was 1.2±0.3. The most frequent aneurysm locations were the anterior communicating artery (64/182, 35.2%), internal carotid artery ophthalmic artery segment (29/182, 15.9%), and middle cerebral artery bifurcation (27/182, 14.8%). Stents were placed in the anticipated anatomic location in all patients. The study met both primary safety and efficacy end points. The composite primary efficacy end point of complete aneurysm occlusion (Raymond-Roy 1) without parent artery stenosis or aneurysm retreatment was achieved in 84.7% (95% CI, 78.6%–90.9%) of patients. Overall, 4.4% (8/182, 95% CI, 1.9%–8.5%) of patients experienced a primary safety end point of major ipsilateral stroke or neurological death. Conclusions: In the ATLAS IDE anterior circulation aneurysm cohort premarket approval study, the Neuroform Atlas stent with adjunctive coiling met the primary end points and demonstrated high rates of long-term complete aneurysm occlusion at 12 months, with 100% technical success and

Published
2020

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