Clinical trial NCT01503775: TRUfill®'s Line in Intracranial aNeurysm Embolisation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysms
Keywords: intracranial
ruptured
non-ruptured
aneurysms
Intracranial ruptured or non-ruptured aneurysms
Lead sponsor: Codman & Shurtleff
Sponsor class: INDUSTRY
First posted: 2012-01-04
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Routine clinical practice

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.


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.

Primary outcomes:
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.
timeFrame: Observed during the procedure and up to 1 year post-procedure follow-up
Secondary outcomes:
measure: The procedural CMMR observed during the procedure and up to 30 Days post procedure follow-up.
timeFrame: Observed during the procedure and up to 30 Days post procedure follow-up.
measure: 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.
timeFrame: Observed at 30 Days and at 1 year post-procedure follow-up
measure: The rate of absence of deterioration or improvement of the neurological status observed at 30 days and at 1 year post procedure follow-up
timeFrame: Observed at 30 days and at 1 year post procedure follow-up
measure: 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
timeFrame: Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up
measure: 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
timeFrame: Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up
measure: The rate of Unanticipated Adverse Device Effects observed during the procedure, at 30 days and up to 1 year post-procedure follow-up
timeFrame: Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up
measure: 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
timeFrame: During the procedure
measure: The rate of recurrent subarachnoid hemorrhage of the treated aneurysm at one-year post-procedure follow-up
timeFrame: 1 year post-procedure
measure: The rate of aneurysm occlusion at the end of the procedure and at 1 year post-procedure follow-up
timeFrame: End of the procedure and at 1 year post-procedure follow-up
measure: 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
timeFrame: Up to 1 year post-treatment
measure: 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
timeFrame: Up to the 1 year post-procedure follow-up
measure: 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
timeFrame: Up to the 1 year post-procedure follow-up
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Colmar
country: France
facility: Hopitaux Civils de Colmar
city: Lyon
country: France
facility: Hôpital Neurologique
city: Marseille
country: France
facility: Clinique Clairval
city: Marseille
country: France
facility: Hôpital Adullte La Timone
city: Paris
country: France
facility: Fondation Rothschild
city: Rennes
country: France
facility: CHU Pontchaillou
Study officials:
References: