Thomas Liebig1, Monika Killer-Oberpfalzer2, Gyula Gal3, Peter Schramm4, Ansgar Berlis5, Franziska Dorn1,6, Olav Jansen1, Jens Fiehler7, Fritz Wodarg1. 1. Institute of Neuroradiology, LMU-University Hospital, Ludwig-Maximilians University, Munich, Germany. 2. Department of Neurology/Institute of Neurointervention, University Hospital Salzburg, Paracelsus Medical University, Salzburg, Austria. 3. Department of Radiology, Odense University Hospital, Odense, Denmark. 4. Department of Neuroradiology, University Hospital of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany. 5. Diagnostic and Interventional Neuroradiology, University Hospital Augsburg, Augsburg, Germany. 6. Department of Neuroradiology, University of Bonn, Bonn, Germany. 7. Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Abstract
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.
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.