NCT01503775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

2.7 years

First QC Date

December 23, 2011

Last Update Submit

June 19, 2017

Conditions

Aneurysms

Keywords

intracranialrupturednon-rupturedaneurysmsIntracranial ruptured or non-ruptured aneurysms

Outcome Measures

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.

    Observed during the procedure and up to 1 year post-procedure follow-up

Secondary Outcomes (12)

  • 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.

  • 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

  • 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

  • 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

  • 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

  • +7 more secondary outcomes

Study Arms (1)

TRUFILL® DCS Orbit Galaxy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Routine clinical practice

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

Hopitaux Civils de Colmar

Colmar, France

Location

Hôpital Neurologique

Lyon, 69394, France

Location

Clinique Clairval

Marseille, France

Location

Hôpital Adullte La Timone

Marseille, France

Location

Fondation Rothschild

Paris, France

Location

CHU Pontchaillou

Rennes, France

Location

MeSH Terms

Conditions

AneurysmRupture

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2011

First Posted

January 4, 2012

Study Start

December 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

June 20, 2017

Record last verified: 2017-06

Locations

FR(7)