Trial · NCT01503775
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | The rate of recurrent subarachnoid hemorrhage of the treated aneurysm at one-year post-procedure follow-up | 1 year post-procedure | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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