• Neurosurgery · Mar 2022

    Multicenter Study

    The Safety and Effectiveness of the Contour Neurovascular System (Contour) for the Treatment of Bifurcation Aneurysms: The CERUS Study.

    • Thomas Liebig, Monika Killer-Oberpfalzer, Gyula Gal, Peter Schramm, Ansgar Berlis, Franziska Dorn, Olav Jansen, Jens Fiehler, and Fritz Wodarg.
    • Institute of Neuroradiology, LMU-University Hospital, Ludwig-Maximilians University, Munich, Germany.
    • Neurosurgery. 2022 Mar 1; 90 (3): 270277270-277.

    BackgroundThe Contour is a novel intra-aneurysmal flow disrupting device to treat intracranial aneurysms.ObjectiveTo evaluate the safety and effectiveness of the Contour device for treatment of nonruptured intracranial bifurcation aneurysms through a prospective, multicenter, single-arm study.MethodsThirty-four patients were enrolled. Primary end points were successful occlusion at 6 mo for efficacy and any major stroke or nonaccidental death up to 30 d or major disabling stroke within 6 mo for safety. Secondary end points were occlusion at 12 mo, retreatment rate, procedure time, and procedure-related/device-related adverse events. Procedural and follow-up imaging was reviewed by an independent core laboratory. Adverse events were reviewed and adjudicated by a clinical events committee.ResultsIn total, 32 of 34 aneurysms were successfully implanted and, 2 of 34 in the intention-to-treat (ITT) group did not receive the Contour and were excluded from follow-up after 30 d. In addition, 2 of 32 were lost to angiographic follow-up and regarded as treatment failure. The primary safety end point was met in 2 patients in the ITT group. In the perprotocol (PP) group, complete occlusion was seen in 14 of 32 (44%) at 6 mo and 22 of 32 (69%) at 12 mo. Adequate occlusion (Raymond-Roy [RR] 1 and 2) was reached in 84% at a last available follow-up. One patient from the ITT group and 1 from the PP group received additional treatment during follow-up.ConclusionThe Contour seems to be both safe and effective in the treatment of intracranial bifurcation aneurysms.Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc on behalf of Congress of Neurological Surgeons.

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…