TRUfill®'s Line in Intracranial aNeurysm Embolisation

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Aneurysms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient ≥ 18 years old Patient presenting one or more ruptured or non-ruptured intracranial aneurysms assessed by angiography Patient implanted with one or more CODMAN TRUFILL® coils Patient agree to take part in the study, or agreement of a representative of the patient in case of patient inability, after being informed by the investigator and have received information letter. Exclusion Criteria: Patient who does not accept to take part in the study after being informed Patient already enrolled in a clinical trial involving experimental medication or device.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TRUFILL® DCS Orbit Galaxy<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Observed during the procedure and up to 1 year post-procedure follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 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 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 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 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 recurrent subarachnoid hemorrhage of the treated aneurysm at one-year post-procedure follow-up |  | 1 year post-procedure | 
| 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 | 
| 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 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 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intracranial, ruptured, non-ruptured, aneurysms, Intracranial ruptured or non-ruptured aneurysms