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

TY - JOUR

T1 - The Safety and Effectiveness of the Contour Neurovascular System (Contour) for the Treatment of Bifurcation Aneurysms: The CERUS Study

AU - Liebig, Thomas

AU - Killer-Oberpfalzer, Monika

AU - Gal, Gyula

AU - Schramm, Peter

AU - Berlis, Ansgar

AU - Dorn, Franziska

AU - Jansen, Olav

AU - Fiehler, Jens

AU - Wodarg, Fritz

N1 - Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc on behalf of Congress of Neurological Surgeons.

PY - 2022/3/1

Y1 - 2022/3/1

N2 - BACKGROUND: The Contour is a novel intra-aneurysmal flow disrupting device to treat intracranial aneurysms.OBJECTIVE: To evaluate the safety and effectiveness of the Contour device for treatment of nonruptured intracranial bifurcation aneurysms through a prospective, multicenter, single-arm study.METHODS: Thirty-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.RESULTS: In 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.CONCLUSION: The Contour seems to be both safe and effective in the treatment of intracranial bifurcation aneurysms.

AB - BACKGROUND: The Contour is a novel intra-aneurysmal flow disrupting device to treat intracranial aneurysms.OBJECTIVE: To evaluate the safety and effectiveness of the Contour device for treatment of nonruptured intracranial bifurcation aneurysms through a prospective, multicenter, single-arm study.METHODS: Thirty-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.RESULTS: In 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.CONCLUSION: The Contour seems to be both safe and effective in the treatment of intracranial bifurcation aneurysms.

U2 - 10.1227/NEU.0000000000001783

DO - 10.1227/NEU.0000000000001783

M3 - SCORING: Journal article

C2 - 35113830

VL - 90

SP - 270

EP - 277

JO - NEUROSURGERY

JF - NEUROSURGERY

SN - 0148-396X

IS - 3

ER -