title: Cerecyte coil trial: angiographic outcomes of a prospective randomized trial comparing endovascular coiling of cerebral aneurysms with either cerecyte or bare platinum coils.
abstract: OBJECTIVE
  We report the primary outcome of the Cerecyte Coil Trial, a randomized trial to determine whether polymer-loaded Cerecyte coils compared with Micrus bare platinum coils improved the proportion of patients with angiographic occlusion of the aneurysm at 6 months when assessed by a core laboratory. The secondary objectives were to compare the clinical outcomes and retreatment rates in the 2 groups.
  
  
  METHODS
  Five hundred patients between 18 and 70 years of age with a ruptured or unruptured target aneurysm were randomized to be treated with either Cerecyte or bare platinum coils in 23 centers worldwide. Two hundred forty-nine patients were assigned to Cerecyte coils and 251 to bare platinum coils. Analysis was by intention to treat.
  
  
  RESULTS
  Four hundred ninety-four patients were eligible for analysis. Four hundred eighty-one patients underwent coil treatment of their aneurysm, 227 patients with recently ruptured aneurysms and 254 with unruptured aneurysms. Four hundred thirty-three follow-up angiograms were assessed by the core laboratory; 127 of 215 (59%) and 118 of 218 (54%) in the Cerecyte and bare platinum groups, respectively, fulfilled the trial prespecified definition of success, namely that the treated aneurysm showed complete angiographic occlusion, had stable neck remnant, or improved in angiographic appearance compared with the end-of-treatment angiogram (P=0.17). Late retreatment was performed in 25 of 452 (5.5%) patients, 17 (7.7%) Cerecyte versus 8 (3.5%) bare platinum (P=0.064; range, 4-34 months). The clinical outcomes did not differ between the groups.
  
  
  CONCLUSIONS
  There was no significant difference at 6 months in the angiographic outcomes between Cerecyte coils and bare platinum coils when assessed by the core laboratory.  Clinical Trial Registration Information- URL: www.controlled-trials.com. Unique Identifier: ISRCTN82461286.
authors: Oxford Neurovascular and Neuroradiology Research Unit, Level 6, West Wing, John Radcliffe Hospital, Oxford UK. andy.molyneux@nds.ox.ac.uk
authors: Andrew J
authors: AJ
authors: Molyneux
authors: Alison
authors: A
authors: Clarke
authors: Mary
authors: M
authors: Sneade
authors: Ziyah
authors: Z
authors: Mehta
authors: Stuart
authors: S
authors: Coley
authors: Daniel
authors: D
authors: Roy
authors: David F
authors: DF
authors: Kallmes
authors: Allan J
authors: AJ
authors: Fox
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002533:Cerebral Angiography; D002561:Cerebrovascular Disorders / Q000000981:diagnostic imaging / Q000628:therapy; D057510:Endovascular Procedures / Q000295:instrumentation* / Q000379:methods*; D004864:Equipment and Supplies; D005500:Follow-Up Studies; D006801:Humans; D002532:Intracranial Aneurysm / Q000000981:diagnostic imaging* / Q000628:therapy*; D008875:Middle Aged; D010984:Platinum; D011108:Polymers; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D011108:Polymers; D010984:Platinum