Safety and Efficacy of the LVIS and LVIS JR Devices in the Endovascular Treatment of Intracranial Aneurysms
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
1 other identifier
observational
130
1 country
20
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2018
Typical duration for all trials
20 active sites
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
February 7, 2018
CompletedFirst Submitted
Initial submission to the registry
May 16, 2018
CompletedFirst Posted
Study publicly available on registry
June 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedJanuary 24, 2024
January 1, 2024
3.4 years
May 16, 2018
January 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mortality Rate
1 year
Morbidity Rate
Number of adverse events with clinical impact related to the procedure and/or the device
1 year
Secondary Outcomes (3)
Clinical effectiveness
1 year
Anatomical effectiveness
1 year
Retreatment rate
1 year
Interventions
Braided coil assist stents used for aneurysm embolization
Eligibility Criteria
All patients with ruptured or not ruptured intracranial aneurysms treated with LVIS or LVIS Jr stent
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Microvention-Terumo, Inc.lead
- Clinactcollaborator
Study Sites (20)
CHU Pellgrin
Bordeaux, France
CHU Caen
Caen, France
CHU Gabriel Montpied
Clermont-Ferrand, France
CHU Michallon
Grenoble, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
CHU Limoges
Limoges, France
Hôpital Clairval
Marseille, France
Hôpital de la Timone
Marseille, France
Hôpital Gui de Chauliac
Montpellier, France
Hôpital Central de Nancy
Nancy, France
Hôpital Pasteur 2
Nice, France
Hôpital Lariboisière
Paris, France
Hôpital Pitié-Salpêtrière
Paris, France
La Fondation Rothschild
Paris, France
Hôpital Maison Blanche
Reims, France
Hôpital Nord
Saint-Etienne, France
Hôpital Foch
Suresnes, France
Hôpital d'instruction des Armées Saint-Anne
Toulon, France
Hôpital Purpan
Toulouse, France
Hôpital Bretonneau
Tours, France
Related Publications (1)
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.
PMID: 37858720DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel Piotin, MD
Fondation Rothschild, Paris, France
- PRINCIPAL INVESTIGATOR
Charbel Mounayer, Prof.
CHU de Limoges, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2018
First Posted
June 12, 2018
Study Start
February 7, 2018
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
January 24, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share