Intracranial AneurysmsTRAILNCT02921711
TRAIL: Treatment of Intracranial Aneurysms With LVIS® System
An observational study of Intracranial Aneurysms, run by Microvention-Terumo, Inc..
Trial summary
A prospective, multicenter, observational assessment of the safety and effectiveness of the LVIS® device in the treatment of wide necked intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- LVIS®
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Apr 2016
- How long will I take part?
- 18 Months
- 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: Patients aged minimum of 18 years with an intracranial aneurysm in whom stent-assisted coiling has been determined to be the appropriate treatment strategy.
Who may be able to join
- Patient or patient's legally authorized representative has been informed about the confidentiality of the study and has agreed to the collection of his/her personal data
- Patient has a ruptured or unruptured intracranial aneurysm for which:
- The parent artery has a diameter ≥ 2.0mm and ≤ 4.5 mm;
- The aneurysm neck size is ≥ 4mm or its dome-to-neck ratio is < 2 (wide neck)
- Endovascular treatment with coils and one or more LVIS® devices has been determined necessary for the patient by the multidisciplinary team
- Patient is aged ≥ 18 years
- Patient presents with a WFNS score between 0 and 3
- Patient has agreed to attend follow-up appointments
Who cannot join
- The use of an endovascular stent other than LVIS® has been determined necessary
- Patient presents with medical or surgical co-morbidities limiting his/her life expectancy to less than one year
- Patient has a contraindication to platelet inhibition treatment
- Patient requires retreatment of an aneurysm previously treated with a stent
- Patient is pregnant
- Patient has multiple aneurysms to be treated in one procedure
About this study
A prospective, multicenter, observational assessment of the safety and effectiveness of the LVIS® device in the treatment of wide necked intracranial aneurysms.
- Conditions
- Intracranial Aneurysms
- Being tested
- LVIS®
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVIS®Device
Low-profile Visualized Intraluminal Support device
| Study group | Role | What they receive |
|---|---|---|
| LVIS® | Not described Receives: Device: LVIS® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm
Measured: 6 months
Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm
Measured: 18 months
Retreatment rate
Measured: 6 months
Retreatment rate
Measured: 18 months
Morbidity rate
Measured: 6 months
Morbidity rate
Measured: 18 months
Mortality rate
Measured: 6 months
Mortality rate
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startJun 2012
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
- More trials run by Microvention-Terumo, Inc.The sponsor's other registered studies.
- 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
- 90 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charbel Mounayer, Prof., Principal investigator, CHU Limoges; Limoges, FranceMichel Piotin, M.D., Principal investigator, Fondation Rothschild; Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921711
- Sponsor's protocol ID
- TRAIL
- Acronym
- TRAIL
- Status last verified
- Jan 2025
- First submitted
- 27 Sep 2016
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRAIL: Treatment of Intracranial Aneurysms With LVIS® System
- ClinicalTrials.gov ID
- NCT02921711
- Acronym / sponsor ID
- TRAIL / TRAIL
- Conditions
- Intracranial Aneurysms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 Oct 2016 (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.
A prospective, multicenter, observational assessment of the safety and effectiveness of the LVIS® device in the treatment of wide necked intracranial aneurysms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LVIS® | – | Device: LVIS® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged minimum of 18 years with an intracranial aneurysm in whom stent-assisted coiling has been determined to be the appropriate treatment strategy.
Key inclusion criteria (8 listed)
- Patient or patient's legally authorized representative has been informed about the confidentiality of the study and has agreed to the collection of his/her personal data
- Patient has a ruptured or unruptured intracranial aneurysm for which:
- Patient is aged ≥ 18 years
- Patient presents with a WFNS score between 0 and 3
- Patient has agreed to attend follow-up appointments
Key exclusion criteria (6 listed)
- The use of an endovascular stent other than LVIS® has been determined necessary
- Patient presents with medical or surgical co-morbidities limiting his/her life expectancy to less than one year
- Patient has a contraindication to platelet inhibition treatment
- Patient requires retreatment of an aneurysm previously treated with a stent
- Patient is pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LVIS®Low-profile Visualized Intraluminal Support device | Device | LVIS® |
Primary outcome
Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm
Time frame: 6 months
Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm
Time frame: 18 months
Retreatment rate
Time frame: 6 months
Retreatment rate
Time frame: 18 months
Morbidity rate
Time frame: 6 months
Morbidity rate
Time frame: 18 months
Mortality rate
Time frame: 6 months
Mortality rate
Time frame: 18 months
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 7 Jan 2025.
- Safety and effectiveness of the Low Profile Visualized Intraluminal Support (LVIS and LVIS Jr) devices in the endovascular treatment of intracranial aneurysms: results of the TRAIL multicenter observational studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Charbel Mounayer, Prof. principal investigator
CHU Limoges; Limoges, France
Michel Piotin, M.D. principal investigator
Fondation Rothschild; Paris, France
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysms, run by Microvention-Terumo, Inc..
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 8 inclusion and 6 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 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm (time frame: 6 months). The study lists 8 primary outcomes in all. 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 7 Jan 2025.