Aneurysms Clinical Trial
— TRULINEOfficial 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
Verified date | June 2017 |
Source | Codman & Shurtleff |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 171 |
Est. completion date | August 1, 2014 |
Est. primary completion date | August 1, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | CHU Clermont-Ferrand | Clermont-Ferrand | |
France | Hopitaux Civils de Colmar | Colmar | |
France | Hôpital Neurologique | Lyon | |
France | Clinique Clairval | Marseille | |
France | Hôpital Adullte La Timone | Marseille | |
France | Fondation Rothschild | Paris | |
France | CHU Pontchaillou | Rennes |
Lead Sponsor | Collaborator |
---|---|
Codman & Shurtleff |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00972790 -
Scalp Nerve Blocks for Post-Craniotomy Pain
|
N/A | |
Completed |
NCT01653769 -
CoSeal for Hemostasis of Aortic Anastamoses
|
N/A | |
Completed |
NCT00703794 -
Researching AXIUM Coiling Experience and Recanalization (RACER)
|
||
Completed |
NCT00288405 -
The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System
|
Phase 1 | |
Completed |
NCT00243893 -
Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms
|
Phase 1 | |
Recruiting |
NCT03642639 -
A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms
|
N/A |