Intracranial AneurysmNCT03553771
Safety and Efficacy of the LVIS and LVIS JR Devices in the Endovascular Treatment of Intracranial Aneurysms
An observational study of Intracranial Aneurysm, run by Microvention-Terumo, Inc. at 20 sites in France.
Trial summary
A French, multicenter, prospective, observational, "real life" assessment of the safety and efficacy of LVIS and LVIS JR devices in the treatment of intracranial aneurysms Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- LVIS and LVIS JR
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 20 sitesFrance
- Study dates
- 7 Feb 2018to 1 Jul 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with ruptured or not ruptured intracranial aneurysms treated with LVIS or LVIS Jr stent
Who may be able to join
- Patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device LVIS or LVIS JR, either scheduled or emergency (" Bail-out stenting ")
- Patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data
Who cannot join
- None
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
CHU Pellgrin
Bordeaux
CHU Caen
Caen
CHU Gabriel Montpied
Clermont-Ferrand
CHU Michallon
Grenoble
Hôpital Bicêtre
Le Kremlin-Bicêtre
CHU Limoges
Limoges
Hôpital Clairval
Marseille
Hôpital de la Timone
Marseille
Hôpital Gui de Chauliac
Montpellier
Hôpital Central de Nancy
Nancy
Hôpital Pasteur 2
Nice
Hôpital Lariboisière
Paris
Hôpital Pitié-Salpêtrière
Paris
La Fondation Rothschild
Paris
Hôpital Maison Blanche
Reims
Hôpital Nord
Saint-Etienne
Hôpital Foch
Suresnes
Hôpital d'instruction des Armées Saint-Anne
Toulon
Hôpital Purpan
Toulouse
Hôpital Bretonneau
Tours
About this study
Official title: A French, Multicenter, Prospective, Observational, "Real Life" Assessment of the Safety and Efficacy of the Low Profile Visualized Intraluminal Support (LVIS and LVIS JR) Devices in the Treatment of Intracranial Aneurysms
A French, multicenter, prospective, observational, "real life" assessment of the safety and efficacy of LVIS and LVIS JR devices in the treatment of intracranial aneurysms
Read the detailed description
This is a multicenter observational study. Treatment and follow-up visits will be done as per standard of care.
The purpose of this study is to collect data on safety of the devices used since the French reimbursement.
130 patients will be enrolled over an 18-month recruitment period. All patients will be followed for at least 12 months.
- Conditions
- Intracranial Aneurysm
- Being tested
- LVIS and LVIS JR
- Keywords
- aneurysm, endovascular
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVIS and LVIS JRDevice
Also called Low Profile Visualized Intraluminal Support
Braided coil assist stents used for aneurysm embolization
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Rate
Measured: 1 year
Morbidity Rate
Number of adverse events with clinical impact related to the procedure and/or the device
Measured: 1 year
Secondary outcomes (3)
Clinical effectiveness
Number of patients with mRS>2
Measured: 1 year
Anatomical effectiveness
Number of patients with complete occlusion of the treated aneurysm
Measured: 1 year
Retreatment rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start7 Feb 2018
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinact
- Responsible party
- Sponsor
- Investigators
- Michel Piotin, MD, Principal investigator, Fondation Rothschild, Paris, FranceCharbel Mounayer, Prof., Principal investigator, CHU de Limoges, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553771
- Sponsor's protocol ID
- LEPI
- Status last verified
- Jan 2024
- First submitted
- 16 May 2018
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Forestier G, Piotin M, Chau Y, Derelle AL, Brunel H, Aggour M, Saleme S, Levrier O, Pierot L, Barreau X, Boubagra K, Janot K, Barbier C, Clarencon F, Chabert E, Spelle L, Arteaga C, Consoli A, Machi P, Blanc R, Rodesch G, Cortese J, Sourour N, Herbreteau D, Heck O, Soize S, Marnat G, Rouchaud A, Anxionnat R, Sedat J, Mounayer C; LEPI investigators. Safety and effectiveness of the LVIS and LVIS Jr devices for the treatment of intracranial aneurysms: Final results of the LEPI multicenter cohort study. J Neuroradiol. 2024 May;51(3):242-248. doi: 10.1016/j.neurad.2023.10.007. Epub 2023 Oct 17.
PubMed 37858720
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A French, Multicenter, Prospective, Observational, "Real Life" Assessment of the Safety and Efficacy of the Low Profile Visualized Intraluminal Support (LVIS and LVIS JR) Devices in the Treatment of Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT03553771
- Acronym / sponsor ID
- LEPI
- Conditions
- Intracranial Aneurysm
- Keywords
- aneurysm, endovascular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Clinact
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 12 Jun 2018 (actual)
- 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 French, multicenter, prospective, observational, "real life" assessment of the safety and efficacy of LVIS and LVIS JR devices in the treatment of intracranial aneurysms
Detailed description
This is a multicenter observational study. Treatment and follow-up visits will be done as per standard of care.
The purpose of this study is to collect data on safety of the devices used since the French reimbursement.
130 patients will be enrolled over an 18-month recruitment period. All patients will be followed for at least 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with ruptured or not ruptured intracranial aneurysms treated with LVIS or LVIS Jr stent
Key inclusion criteria (2 listed)
- Patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device LVIS or LVIS JR, either scheduled or emergency (" Bail-out stenting ")
- Patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data
Key exclusion criteria (1 listed)
- None
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 and LVIS JRAlso: Low Profile Visualized Intraluminal SupportBraided coil assist stents used for aneurysm embolization | Device | – |
Primary outcome
Mortality Rate
Time frame: 1 year
Morbidity Rate
Time frame: 1 year
Number of adverse events with clinical impact related to the procedure and/or the device
3 secondary outcomes
Clinical effectiveness
Time frame: 1 year
Anatomical effectiveness
Time frame: 1 year
Retreatment rate
Time frame: 1 year
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 24 Jan 2024.
- Derived from this study: PubMed 37858720Forestier G, Piotin M, Chau Y, Derelle AL, Brunel H, Aggour M, Saleme S, Levrier O, Pierot L, Barreau X, Boubagra K, Janot K, Barbier C, Clarencon F, Chabert E, Spelle L, Arteaga C, Consoli A, Machi P, Blanc R, Rodesch G, Cortese J, Sourour N, Herbreteau D, Heck O, Soize S, Marnat G, Rouchaud A, Anxionnat R, Sedat J, Mounayer C; LEPI investigators. Safety and effectiveness of the LVIS and LVIS Jr devices for the treatment of intracranial aneurysms: Final results of the LEPI multicenter cohort study. J Neuroradiol. 2024 May;51(3):242-248. doi: 10.1016/j.neurad.2023.10.007. Epub 2023 Oct 17.
- Safety and effectiveness of the LVIS and LVIS Jr devices for the treatment of intracranial aneurysms: Final results of the LEPI multicenter cohort studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Michel Piotin, MD principal investigator
Fondation Rothschild, Paris, France
Charbel Mounayer, Prof. principal investigator
CHU de Limoges, France
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Microvention-Terumo, Inc. at 20 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 2 inclusion and 1 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 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
Mortality Rate (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03553771, which also lists 1 linked publication.
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 24 Jan 2024.