TRUfill®'s Line in Intracranial aNeurysm Embolisation

Aneurysms Clinical Trial

— TRULINE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503775
• Other study ID #: NV-PMK-0902
• Status: Completed
• Phase: N/A
• First received: December 23, 2011
• Last updated: June 19, 2017
• Start date: December 1, 2011
• Est. completion date: August 1, 2014

Study information

• Verified date: June 2017
• Source: Codman & Shurtleff
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Aneurysm
• Aneurysms
• Intracranial Aneurysm

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Codman & Shurtleff

Country where clinical trial is conducted

France, 

Outcome

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