LVIS™ Coil Assist Stent
LEPI: Safety and Efficacy of the LVIS™ and LVIS™ Jr Devices in the Endovascular Treatment of Intracranial Aneurysms
"This study provides evidence that the LVIS™/LVIS™ Jr devices are safe and effective in the treatment of complex intracranial aneurysms, with very high rates of adequate occlusion at FU. These angiographic results are stable over time with an acceptable complication rate."
- Patients
130
- Country
France
- Clinical Centers
17
- Design
Single arm prospective
- Scope
Patients with ruptured or unruptured aneurysms treated with LVIS™/LVIS™ Jr in France.
- Purpose
Collect data on safety of the LVIS™/LVIS™ Jr devices used in a routine practice post reimbursement in France.
Endpoints
Cumulative morbidity and mortality rate (CMMR) assessed at 12-month follow-up, defined by the incidence of adverse events (AEs) with sequelae related to the treatment and/or device
Efficacy results
Treatment success: 100%
At 16.8 months:
Complete/nearly complete occlusion: 92.6%
Retreatment rate: 2.5%
Safety results
1 year:
Mobi-mortality related to the procedure and/or device: 4.6%
Overall mortality: 1.5%, none related to the procedure and/or device
LINK TO STUDY PAGE ClinicalTrials.gov ID NCT03553771
Please refer to IFU for the full list of risks, contraindications, warnings, and precautions.
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