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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRUFILL® DCS Orbit Galaxy |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Routine clinical practice
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | France | ||||
| Hopitaux Civils de Colmar |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D012421 | Rupture |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014947 | Wounds and Injuries |
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| 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 |
| Colmar |
| France |
| Hôpital Neurologique | Lyon | 69394 | France |
| Clinique Clairval | Marseille | France |
| Hôpital Adullte La Timone | Marseille | France |
| Fondation Rothschild | Paris | France |
| CHU Pontchaillou | Rennes | France |