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: October 10, 2013
Last verified: October 2013
  Purpose

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
Aneurysms

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Codman & Shurtleff:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 165
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
TRUFILL® DCS Orbit
TRUFILL® DCS Orbit Galaxy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01503775

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

No publications provided

Responsible Party: Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT01503775     History of Changes
Other Study ID Numbers: NV-PMK-0902
Study First Received: December 23, 2011
Last Updated: October 10, 2013
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Conseil National de l'Ordre des Médecins
France: The Commission nationale de l’informatique et des libertés
France: Institutional Ethical Committee

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

ClinicalTrials.gov processed this record on April 14, 2014