TRUfill®'s Line in Intracranial aNeurysm Embolisation (TRULINE)

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.

Study Overview

• Status: Completed
• Conditions: Aneurysms

• Study Type: Observational
• Enrollment (Actual): 171

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU clermont-ferrand
  • Colmar, France
    • Hôpitaux civils de Colmar
  • Lyon, France, 69394
    • Hôpital neurologique
  • Marseille, France
    • Clinique Clairval
  • Marseille, France
    • Hôpital Adullte La Timone
  • Paris, France
    • Fondation Rothschild
  • Rennes, France
    • CHU Pontchaillou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Routine clinical practice

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
TRUFILL® DCS Orbit Galaxy

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Codman & Shurtleff

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2011
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: December 23, 2011
• First Submitted That Met QC Criteria: December 31, 2011
• First Posted (ESTIMATE): January 4, 2012

Study Record Updates

• Last Update Posted (ACTUAL): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: intracranial; aneurysms; ruptured; non-ruptured; Intracranial ruptured or non-ruptured aneurysms
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: NV-PMK-0902