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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT01503775
First received: December 23, 2011
Last updated: July 8, 2014
Last verified: July 2014

December 23, 2011
July 8, 2014
December 2011
September 2014   (final data collection date for primary outcome 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. [ Time Frame: Observed during the procedure and up to 1 year post-procedure follow-up ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01503775 on ClinicalTrials.gov Archive Site
  • The procedural CMMR observed during the procedure and up to 30 Days post procedure follow-up. [ Time Frame: Observed during the procedure and up to 30 Days post procedure follow-up. ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Observed at 30 Days and at 1 year post-procedure follow-up ] [ Designated as safety issue: Yes ]
  • The rate of absence of deterioration or improvement of the neurological status observed at 30 days and at 1 year post procedure follow-up [ Time Frame: Observed at 30 days and at 1 year post procedure follow-up ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up ] [ Designated as safety issue: Yes ]
  • The rate of Unanticipated Adverse Device Effects observed during the procedure, at 30 days and up to 1 year post-procedure follow-up [ Time Frame: Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: During the procedure ] [ Designated as safety issue: Yes ]
  • The rate of recurrent subarachnoid hemorrhage of the treated aneurysm at one-year post-procedure follow-up [ Time Frame: 1 year post-procedure ] [ Designated as safety issue: Yes ]
  • The rate of aneurysm occlusion at the end of the procedure and at 1 year post-procedure follow-up [ Time Frame: End of the procedure and at 1 year post-procedure follow-up ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Up to 1 year post-treatment ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Up to the 1 year post-procedure follow-up ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Up to the 1 year post-procedure follow-up ] [ Designated as safety issue: No ]
  • The procedural CMMR observed during the procedure and up to 30 Days post procedure follow-up. [ Time Frame: Observed during the procedure and up to 30 Days post procedure follow-up. ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Observed at 30 Days and at 1 year post-procedure follow-up ] [ Designated as safety issue: Yes ]
  • The rate of absence of deterioration or improvement of the neurological status observed at 30 days and at 1 year post procedure follow-up [ Time Frame: Observed at 30 days and at 1 year post procedure follow-up ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up ] [ Designated as safety issue: Yes ]
  • The rate of Unanticipated Adverse Device Effects observed during the procedure, at 30 days and up to 1 year post-procedure follow-up [ Time Frame: Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Procedure through 1 year follow-up ] [ Designated as safety issue: Yes ]
  • The rate of recurrent subarachnoid hemorrhage of the treated aneurysm at one-year post-procedure follow-up [ Time Frame: Up to 1 year post-procedure follow-up ] [ Designated as safety issue: Yes ]
  • The rate of aneurysm occlusion at the end of the procedure and at 1 year post-procedure follow-up [ Time Frame: End of the procedure and at 1 year post-procedure follow-up ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Up to 1 year post-treatment ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Up to the 1 year post-procedure follow-up ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Up to the 1 year post-procedure follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Routine clinical practice

Aneurysms
Not Provided
TRUFILL® DCS Orbit Galaxy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
171
December 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01503775
NV-PMK-0902
Yes
Codman & Shurtleff
Codman & Shurtleff
Not Provided
Not Provided
Codman & Shurtleff
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP