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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01503775
Recruitment Status : Completed
First Posted : January 4, 2012
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff

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.

Condition or disease
Aneurysms

Study Type : Observational
Actual Enrollment : 171 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 1, 2011
Primary Completion Date : August 1, 2014
Study Completion Date : August 1, 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
TRUFILL® DCS Orbit Galaxy



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. The rate of recurrent subarachnoid hemorrhage of the treated aneurysm at one-year post-procedure follow-up [ Time Frame: 1 year post-procedure ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Routine clinical practice
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503775


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France
Hopitaux Civils de Colmar
Colmar, France
Hôpital Neurologique
Lyon, France, 69394
Clinique Clairval
Marseille, France
Hôpital Adullte La Timone
Marseille, France
Fondation Rothschild
Paris, France
CHU Pontchaillou
Rennes, France
Sponsors and Collaborators
Codman & Shurtleff

Responsible Party: Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT01503775     History of Changes
Other Study ID Numbers: NV-PMK-0902
First Posted: January 4, 2012    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

Keywords provided by Codman & Shurtleff:
intracranial
ruptured
non-ruptured
aneurysms
Intracranial ruptured or non-ruptured aneurysms

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases