• 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.

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