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| Name | Class |
|---|---|
| Clinact | OTHER |
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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LVIS and LVIS JR | Device | Braided coil assist stents used for aneurysm embolization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rate | 1 year | |
| Morbidity Rate | Number of adverse events with clinical impact related to the procedure and/or the device | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical effectiveness | Number of patients with mRS>2 | 1 year |
| Anatomical effectiveness | Number of patients with complete occlusion of the treated aneurysm |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with ruptured or not ruptured intracranial aneurysms treated with LVIS or LVIS Jr stent
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| Name | Affiliation | Role |
|---|---|---|
| Michel Piotin, MD | Fondation Rothschild, Paris, France | Principal Investigator |
| Charbel Mounayer, Prof. | CHU de Limoges, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Pellgrin | Bordeaux | France | ||||
| CHU Caen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37858720 | Derived | 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. |
| Label | URL |
|---|---|
| Safety and effectiveness of the LVIS and LVIS Jr devices for the treatment of intracranial aneurysms: Final results of the LEPI multicenter cohort study | View source |
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| 1 year |
| Retreatment rate | 1 year |
| 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 |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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