Cerecyte Coil Trial

• DOI: 10.1161/strokeaha.112.657254
• Publication Date: 2012-07-27T20:58:20Z
• Authors: Andrew J. Molyneux; Alison Clarke; Mary Sneade; Ziyah Mehta; Stuart Coley; Daniel Roy; David F. Kallmes; Allan J. Fox
• Keywords: Adult; Adolescent; Polymers; Endovascular Procedures; Intracranial Aneurysm; Middle Aged; Cerebral Angiography; 3. Good health; Cerebrovascular Disorders; Young Adult; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Equipment and Supplies; Humans; Single-Blind Method; Aged; Follow-Up Studies; Platinum

Background and Purpose— We report the primary outcome of Cerecyte Coil Trial, a randomized trial to determine whether polymer-loaded coils compared with Micrus bare platinum improved proportion patients angiographic occlusion aneurysm at 6 months when assessed by core laboratory. The secondary objectives were compare clinical outcomes retreatment rates in 2 groups. Methods— Five hundred between 18 70 years age ruptured or unruptured target be treated either 23 centers worldwide. Two forty-nine assigned 251 coils. Analysis was intention treat. Results— Four ninety-four eligible for analysis. eighty-one underwent coil treatment their aneurysm, 227 recently aneurysms 254 aneurysms. thirty-three follow-up angiograms laboratory; 127 215 (59%) 118 218 (54%) groups, respectively, fulfilled prespecified definition success, namely that showed complete occlusion, had stable neck remnant, appearance end-of-treatment angiogram ( P =0.17). Late performed 25 452 (5.5%) patients, 17 (7.7%) versus 8 (3.5%) =0.064; range, 4–34 months). did not differ Conclusion— There no significant difference Clinical Trial Registration Information— URL: www.controlled-trials.com . Unique Identifier: ISRCTN82461286.