The objective of this study is to evaluate the long term efficacy and safety of the CODMAN TRUFILL®'s line of coils in the treatment of patients with intracranial ruptured or non-ruptured aneurysms in real-life routine clinical practice.
Study Type
OBSERVATIONAL
Enrollment
171
CHU Clermont-Ferrand
Clermont-Ferrand, France
Hopitaux Civils de Colmar
Colmar, France
Hôpital Neurologique
Lyon, France
Clinique Clairval
Marseille, France
The long term safety of the coiling procedure with the CODMAN TRUFILL®'s line of coils will be assessed by the combined morbidity-mortality rate (CMMR) observed during the procedure and up to 1 year post-procedure follow-up.
Time frame: Observed during the procedure and up to 1 year post-procedure follow-up
The procedural CMMR observed during the procedure and up to 30 Days post procedure follow-up.
Time frame: Observed during the procedure and up to 30 Days 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.
Time frame: Observed at 30 Days and at 1 year post-procedure follow-up
The rate of absence of deterioration or improvement of the neurological status observed at 30 days and at 1 year post procedure follow-up
Time frame: 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
Time frame: Observed during the procedure, at 30 days and up to 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
Time frame: Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up
The rate of Unanticipated Adverse Device Effects observed during the procedure, at 30 days and up to 1 year post-procedure follow-up
Time frame: Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up
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Hôpital Adullte La Timone
Marseille, France
Fondation Rothschild
Paris, France
CHU Pontchaillou
Rennes, France
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
Time frame: During the procedure
The rate of recurrent subarachnoid hemorrhage of the treated aneurysm at one-year post-procedure follow-up
Time frame: 1 year post-procedure
The rate of aneurysm occlusion at the end of the procedure and at 1 year post-procedure follow-up
Time frame: End of the procedure and at 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
Time frame: Up to 1 year post-treatment
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
Time frame: Up to the 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
Time frame: Up to the 1 year post-procedure follow-up