AneurysmsTRULINENCT01503775
TRUfill®'s Line in Intracranial aNeurysm Embolisation
An observational study of Aneurysms, run by Codman & Shurtleff at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysms
- How many people
- 171 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Dec 2011to 1 Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Routine clinical practice
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU Clermont-Ferrand
Clermont-Ferrand
Hopitaux Civils de Colmar
Colmar
Hôpital Neurologique
Lyon, 69394
Clinique Clairval
Marseille
Hôpital Adullte La Timone
Marseille
Fondation Rothschild
Paris
CHU Pontchaillou
Rennes
About this study
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
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.
- Conditions
- Aneurysms
- Keywords
- intracranial, ruptured, non-ruptured, aneurysms, Intracranial ruptured or non-ruptured aneurysms
- Medical subject headings
- Aneurysm, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TRUFILL® DCS Orbit Galaxy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up
The rate of Unanticipated Adverse Device Effects observed during the procedure, at 30 days and up to 1 year post-procedure follow-up
Measured: Observed during the procedure, at 30 days and up to 1 year post-procedure follow-up
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
Measured: During the procedure
The rate of recurrent subarachnoid hemorrhage of the treated aneurysm at one-year post-procedure follow-up
Measured: 1 year post-procedure
The rate of aneurysm occlusion at the end of the procedure and at 1 year post-procedure follow-up
Measured: End of the procedure and at 1 year post-procedure follow-up
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
Measured: Up to 1 year post-treatment
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
Measured: Up to the 1 year post-procedure follow-up
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
Measured: Up to the 1 year post-procedure follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study start1 Dec 2011
- Primary completion1 Aug 2014
- Study completion1 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codman & Shurtleff
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503775
- Sponsor's protocol ID
- NV-PMK-0902
- Acronym
- TRULINE
- Status last verified
- Jun 2017
- First submitted
- 23 Dec 2011
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01503775
- Acronym / sponsor ID
- TRULINE / NV-PMK-0902
- Conditions
- Aneurysms
- Keywords
- intracranial, ruptured, non-ruptured, aneurysms, Intracranial ruptured or non-ruptured aneurysms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Codman & ShurtleffIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 1 Aug 2014 (actual)
- Study completion
- 1 Aug 2014 (actual)
- First posted
- 4 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRUFILL® DCS Orbit Galaxy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Routine clinical practice
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
12 secondary outcomes
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.
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
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
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
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
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
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
The rate of recurrent subarachnoid hemorrhage of the treated aneurysm at one-year post-procedure follow-up
Time frame: 1 year post-procedure
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysms, run by Codman & Shurtleff at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.