LVIS™ Coil Assist Stent
TRAIL: Treatment of Intracranial Aneurysms With LVIS™ System
"The LVIS™/LVIS™ Jr endovascular devices are safe and effective in the treatment of ruptured and unruptured intracranial aneurysms, with acceptable complication rates, very high immediate total occlusion rates, and stable angiographic results."
- Patients
90
- Country
France
- Clinical Centers
10
- Design
Single arm prospective
- Scope
Patients ≥ 18 y.o. with an unruptured or ruptured, aneurysm, neck size ≥ 4mm or dome-to-neck ratio < 2, WFNS < 4, eligible to be treated with coils and LVIS™/LVIS™ Jr stent.
- Purpose
Assess safety and effectiveness of the LVIS™/ LVIS™ Jr devices in the treatment of wide necked intracranial aneurysms to obtain reimbursement in France.
Endpoints
Efficacy:
Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm at 6 and 18 months (assessed by Corelab)
Retreatment rate at 6 and 18 months
Safety:
Morbidity (mRS>2) rate at 6 and 18 months
Mortality rate at 6 and 18 months
Efficacy results
At 6 months:
Stent stability: 100%
Parent artery patency: 100%
Complete occlusion: 91.0%
At 18 months:
Stent stability: 100%
Parent artery patency: 100%
Complete occlusion: 92.4 %
Retreatment rate: 1.1%
Safety results
At 6 months:
Permanent morbidity (procedure-related AEs with sequelae): 4.4% (incl. 1.25% of patients with mRS>2)
At 18 months:
Morbidity & Mortality (mRS >2): 5.6%
Overall AEs with sequelae related to the stent: 2.2%
LINK TO STUDY PAGE ClinicalTrials.gov ID NCT02921711
Please refer to IFU for the full list of risks, contraindications, warnings, and precautions.
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