Evidence map›Paper›PMID 30670625›Full record

Trial reportJournal of neurointerventional surgery2019

Neuroform Atlas Stent System for the treatment of intracranial aneurysm: primary results of the Atlas Humanitarian Device Exemption cohort.

Brian T Jankowitz, Ricardo Hanel, Ashutosh P Jadhav, David N Loy, Donald Frei, Adnan H Siddiqui, Ajit S Puri, Ahmad Khaldi, Aquilla S Turk, Adel M Malek and 3 more

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Journal of neurointerventional surgery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  6. Article
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  8. Use of the neuroform atlas for stenting of intracranial atherosclerotic disease: Clinical and angiographic outcomes.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026
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  14. Optional or optimal? off-label stenting for intracranial atherosclerotic stenosis: A scoping review.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2025
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  20. Inverted stent deployment technique for stent assisted coiling of wide-necked posterior communicating artery aneurysm: Technical report.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Brian T Jankowitz *Department of Neurological Surgery, UPMC Presbyterian Hospital, Pittsburgh, Pennsylvania, USA.
Ricardo HanelLyerly Neurosurgery, Jacksonville, Florida, USA.
Ashutosh P JadhavDepartment of Neurology, UPMC Presbyterian Hospital, Pittsburgh, Pennsylvania, USA.
David N LoyRadiology, University of Virginia, Richmond, Virginia, USA.
Donald FreiDepartment of Radiology, Swedish Medical Center, Denver, Colorado, USA.
Adnan H SiddiquiUniversity at Buffalo Neurosurgery, Buffalo, New York, USA.ORCID http://orcid.org/0000-0002-9519-0059
Ajit S PuriDepartment of Radiology, University of Massachusetts, Worcester, Massachusetts, USA.
Ahmad KhaldiNeurosurgery at WellStar Kennestone Hospital, Medical University of South Carolina, Charleston, South Carolina, USA.
Aquilla S TurkDepartment of Radiology, Medical University of South Carolina, Charleston, South Carolina, USA.
Adel M MalekDepartment of Neurosurgery, Tufts Medical Center, Boston, Massachusetts, USA.
Eric SauvageauLyerly Neurosurgery, Jacksonville, Florida, USA.
Steven W HettsInterventional Neuroradiology, The University of California San Francisco, San Francisco, California, USA.
Osama O Zaidat *Neuroscience Department, Bon Secours Mercy Health St Vincent Medical Center, Toledo, USA.ORCID http://orcid.org/0000-0003-4881-4698

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveStent-assisted coil embolization is a well-established treatment of intracranial wide-necked aneurysms. The Neuroform Atlas Stent System is a new generation microstent designed to enhance coil support, conformability, deliverability, and improve deployment accuracy. We present the 1-year efficacy and angiographic results of the Humanitarian Device Exemption (HDE) cohort from the Atlas Investigational Device Exemption (IDE) clinical trial.

methodThe Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of unruptured wide-necked intracranial aneurysms treated with the Neuroform Atlas stent and approved coils. The primary efficacy endpoint was the rate of 12-month complete aneurysm angiographic occlusion (Raymond class I) without target aneurysm retreatment or significant parent artery stenosis (>50%) at the target location. The primary safety endpoint was the rate of major ipsilateral stroke or neurological death within 12 months. Imaging core laboratory and Clinical EventsCommittee adjudicated the primary endpoints.

results30 patients were enrolled at eight US centers, with 27 patients completing the 12-month angiographic follow-up. The mean age was 59.4±11.8 years and 24/30 patients (80%) were women. The mean aneurysm size was 5.3±1.7 mm and the dome:neck ratio was 1.1±0.2. Procedural technical success of Neuroform Atlas Stent deployment was 100%. 27 patients completed 12-month angiographic follow-up and 30 patients completed their 6-month follow-up. When applying the last observation carried forward method, the primary efficacy endpoint was observed in 26/30 patients (86.7%, 95% CI 69.3% to 96.2%) compared with 25/27 patients (92.6%, 95% CI 75.7% to 99.1%) who completed the 12-month angiographic follow-up. The primary safety endpoint of stroke occurred in one patient (3.3%), who made a complete clinical recovery at discharge. There were no neurological deaths.

conclusionThe Neuroform Atlas stent in conjunction with coils demonstrated a high rate of complete aneurysm occlusion at 12-month angiographic follow-up, with an improved safety profile in the HDE cohort. CLINICAL TRIALGOV REGISTRATION NUMBER: NCT0234058;Results.

Indexed as

Self Expandable Metallic StentsAdultAgedBlood Vessel ProsthesisCerebral AngiographyCohort StudiesCompassionate Use TrialsEmbolization, TherapeuticFemaleHumansIntracranial AneurysmMaleMiddle AgedPatient DischargeProspective StudiesRetreatmentATLASatlas stentcerebral aneurysmneuroformstent-assisted coilingwide-neck aneurysm

Identifiers

PMID30670625
PMCPMC6703120

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.