Pivotal Trial of the Neuroform Atlas Stent for Treatment of Anterior Circulation Aneurysms
Author:
Zaidat Osama O.1ORCID, Hanel Ricardo A.2, Sauvageau Eric A.2, Aghaebrahim Amin2, Lin Eugene1, Jadhav Ashutosh P.3, Jovin Tudor G.4, Khaldi Ahmad5, Gupta Rishi G.5, Johnson Andrew6, Frei Donald7, Loy David8, Malek Adel9, Toth Gabor10, Siddiqui Adnan11, Reavey-Cantwell John12, Thomas Ajith13, Hetts Steven W.14, Jankowitz Brian T.15, Gross Bradley, Ducruet Andrew, Panczkowski David, Shoirah Hazem, Al-Bayati Alhamza, Weiner Greg, Kenmuir Cynthia, Tadi Prasanna, Walker Gregory, Johnson K., Frei Don, Bellon Richard, Atchie Benjamin, Kaminsky Ian, Huddle Dan, Bain Mark, Rasmussen Peter, Hussain M. Shazam, Moore Nina, Masaryk Thomas, Elgabaly Mohamed, Cerejo Russell, Hardman Julian, John Seby, Bauer Andrew, Peih-Chir Tsai Jenny, Levy Elad, Snyder Kenneth, Davies Jason, Ogilvy Christopher, Rivet Dennis, Alexander Michael, Moser Franklin, Maya Marcel, Schiraldi Michael, Eboli Paula, Caplan Justin, Jiang Bowen, Bender Matthew, Colby Geoffrey, Satti Sudhakar, Sivapatham Thinesh, Kung David, Pukenas Bryan, Hurst Robert, Smith Michelle J., Puri Ajit, Massari Francesco, Rex David, Fraser Justin, Grupke Stephen, Alhajeri Abdulnasser, Klucznik Richard, Diaz Orlando, Britz Gavin, Zhan Yi, Spiotta Alejandro, Lena Jonathan, Turk Aquilla, Chaudry Mohamad, Fargen Kyle, Turner Raymond, Kan Peter, Duckworth Edward, Asif Taqi Muhammad, Hou Samuel, Arthur Adam S., Elijovich Lucas, Hoit Daniel, Nickele Christopher, Vachhani Jay, Thomas Doss Vinodh, Crowley Richard, Lopes Demetrius, Chen Michael, Hallam Danial, Ghodke Basavaraj, Kim Louis, Callison Richard, Alshekhlee Amer, Kale Sushant, Froehler Michael, Fusco Matt, Chitale Rohan
Affiliation:
1. Neuroscience Department, Bon Secours Mercy Health St. Vincent Medical Center, Toledo, OH (O.O.Z., E.L.). 2. Lyerly Neurosurgery, Jacksonville, FL (R.A.H., E.A.S., A.A.). 3. The Stroke Institute, Department of Neurology, University of Pittsburgh Medical Center, PA (A.P.J.). 4. Cooper University Hospital Neurological Institute, Camden, NJ (T.G.J.). 5. WellStar Medical Group, Neurosurgery WellStar Health System, Marietta, GA (A.K., R.G.G.). 6. Swedish Covenant Hospital Neurosurgery, Chicago, IL (A.J.). 7. Radiology Imaging Associates, Swedish Medical Center, Englewood, CO (D.F.). 8. Department of Radiology and Medical Imaging, University of Virginia, Charlottesville (D.L.). 9. Department of Neurosurgery, Tufts Medical Center, Boston, MA (A.M.). 10. Cerebrovascular Center, Cleveland Clinic, OH (G.T.). 11. SUNY University at Buffalo, NY (A.S.). 12. Virginia Commonwealth University Medical Center, Richmond (J.R.-C.). 13. Beth Israel Deaconess Medical Center, Boston, MA (A.T.). 14. Interventional Neuroradiology, University of California San Francisco, San Francisco (S.W.H.). 15. Cooper University Hospital, Camden (B.T.J.).
Abstract
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 <2) intracranial aneurysms in the anterior circulation treated with the Neuroform Atlas Stent and approved coils. The primary efficacy end point was complete aneurysm occlusion (Raymond-Roy class 1) on 12-month angiography, in the absence of retreatment 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 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 <5% morbidity.
Registration:
URL:
https://www.clinicaltrials.gov
. Unique identifier: NCT02340585.
Publisher
Ovid Technologies (Wolters Kluwer Health)
Subject
Advanced and Specialised Nursing,Cardiology and Cardiovascular Medicine,Clinical Neurology
Cited by
50 articles.
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