TRUfill®'s Line in Intracranial aNeurysm Embolisation (TRULINE)
This study is currently recruiting participants.
Verified February 2013 by Codman & Shurtleff
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT01503775
First received: December 23, 2011
Last updated: February 12, 2013
Last verified: February 2013
| December 23, 2011 |
| February 12, 2013 |
| December 2011 |
| June 2014 (final data collection date for primary outcome measure) |
| 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 ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT01503775 on ClinicalTrials.gov Archive Site |
- 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. ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- The rate of recurrent subarachnoid hemorrhage of the treated aneurysm at one-year post-procedure follow-up [ Time Frame: 1 year post-procedure ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|
- 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. ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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: Procedure through 1 year follow-up ] [ Designated as safety issue: Yes ]
- The rate of recurrent subarachnoid hemorrhage of the treated aneurysm at one-year post-procedure follow-up [ Time Frame: Up to 1 year post-procedure follow-up ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
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| Not Provided |
| Not Provided |
| |
| TRUfill®'s Line in Intracranial aNeurysm Embolisation |
| 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 |
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. |
| Not Provided |
| Observational |
Observational Model: Cohort Time Perspective: Prospective |
| Not Provided |
| Not Provided |
| Non-Probability Sample |
Routine clinical practice |
| Aneurysms |
| Not Provided |
- TRUFILL® DCS Orbit
- TRUFILL® DCS Orbit Galaxy
|
| Not Provided |
| |
| Recruiting |
| 165 |
| December 2014 |
| June 2014 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years and older |
| No |
|
|
| France |
| |
| NCT01503775 |
| NV-PMK-0902 |
| No |
| Codman & Shurtleff |
| Codman & Shurtleff |
| Not Provided
| Not Provided
| Codman & Shurtleff |
| February 2013 |