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

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 fromfollow-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 wasmet in 2 patients in the ITT group. In the perprotocol (PP) group, complete occlusion was seen in 14 of 32 (44%) at 6mo 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.

Automated summary

The study evaluated the safety and effectiveness of the Contour device for treating nonruptured bifurcation aneurysms. The results showed that the Contour device is both safe and effective in treating these aneurysms.