A Prospective, Multicentric Observational Study Evaluating the Long Term Efficacy and Safety of the CODMAN TRUFILL®'s Line of Coils in the Endovascular Treatment of Intracranial Aneurysms

简要总结

主要结局

次要结局

• The rate of Unanticipated Adverse Device Effects observed during the procedure, at 30 days and up to 1 year post-procedure follow-up(Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up)
• The rate of retreatment at 1 year follow-up representing the rate of major recurrence on the target aneurysm observed up to the 1 year post-procedure follow-up(Up to the 1 year post-procedure follow-up)
• The rate of permanent morbidity and mortality observed at 30 Days and at 1 year post-procedure follow-up, defined as a mRS of 3 to 6.(Observed at 30 Days and at 1 year post-procedure follow-up)
• The rate of Adverse Event/Serious Adverse Event related to the device and/or to the procedure observed during the procedure, at 30 days and up to 1 year post-procedure follow-up(Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up)
• The rate of aneurysm recanalisation up to 1 year post-treatment defined as any increase in the size of the remnant or defined as a change of classification of the Raymond scale result related up to the 1 year post-procedure follow-up(Up to 1 year post-treatment)
• The rate of absence of deterioration or improvement of the neurological status observed at 30 days and at 1 year post procedure follow-up(Observed at 30 days and at 1 year post procedure follow-up)
• The overall rate of Adverse Event/Serious Adverse Event observed during the procedure, at 30 days and up to 1 year post-procedure follow-up(Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up)
• The rate of recurrent subarachnoid hemorrhage of the treated aneurysm at one-year post-procedure follow-up(1 year post-procedure)
• The rate of per-procedural subarachnoid hemorrhage of the treated aneurysm and rate of per-procedural SAH leading to a modification of the procedure initially planned(During the procedure)
• The rate of spontaneous aneurysm regression up to 1 year post-treatment defined as any decrease in the size of the remnant or defined as a change of classification of the Raymond scale result related up to the 1 year post-procedure follow-up(Up to the 1 year post-procedure follow-up)
• The procedural CMMR observed during the procedure and up to 30 Days post procedure follow-up.(Observed during the procedure and up to 30 Days post procedure follow-up.)
• The rate of aneurysm occlusion at the end of the procedure and at 1 year post-procedure follow-up(End of the procedure and at 1 year post-procedure follow-up)