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OpenTrials
Completed

NCT Number: NCT01503775

TRUfill®'s Line in Intracranial aNeurysm Embolisation

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.

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Key information

Conditions

Aneurysms Aneurysm Cardiovascular Diseases Rupture Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Codman & Shurtleff

Industry

Registry information

Official study 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

Acronym: TRULINE

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 4, 2012
Registry last updated
Jun 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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