Abstract
Endovascular coil occlusion of cerebral aneurysms is increasing as a viable treatment for both ruptured and unruptured aneurysms. The purpose of this study was to evaluate the safety and performance of a newer generation of complex-shaped, geometrically conformable, platinum coils, the TRUFILL DCS Detachable Coil System. From September 2000 to December 2002, 112 patients with 116 aneurysms, either ruptured or unruptured, deemed by an attending neuro-in-terventionalist to be acceptable candidates for endovascular coil embolization, were recruited into an open-label, prospective, multi-center, international registry study from 23 centers in Europe. Information on relevant clinical characteristics, device and procedure performance, and angiographic occlusion data were collected for all patients. An Independent Medical Monitor collected and reviewed information on all device- and procedure-related complications resulting in serious adverse events. Angiographic evaluation immediately following treatment of 116 aneurysms showed a mean ± SD percent of aneurysm occlusion of 93.5% ± 14.2, with 90.2% of aneurysms occluded at least 90%. The desired occlusion was achieved in 94.9% of aneurysms. Success was defined as the ability to obtain ≥ 90% aneurysm occlusion. The proportion achieving greater than 90% occlusion was statistically equivalent (at least as good) to the 80% registry standard. Complication rates were 6.9% device-related and 2.6% procedure-related. Only two complications were categorized as serious adverse events. The TRUFILL DCS coil system provided good to excellent complete occlusion of the aneurysm at initial treatment, as compared to other published studies, and proved effective and safe to use in treating both ruptured and unruptured cerebral aneurysms.
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