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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01503775

Acronym

TRULINE

Enrollment

171

Registered

2012-01-04

Start date

2011-12-01

Completion date

2014-08-01

Last updated

2017-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysms

Keywords

intracranial, ruptured, non-ruptured, aneurysms, Intracranial ruptured or non-ruptured aneurysms

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Secondary

Measure	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.	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

Countries

France

Outcome results