LVIS™ Coil Assist Stent
HDE Study: Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support) Device
"The LVIS™ device facilitated the coil embolization of wide-necked intracranial aneurysms with high rates of technical success, an excellent safety profile, and very high rates of complete and near-complete occlusion at follow-up."
- Patients
31
- Country
US
- Clinical Centers
6
- Design
Single arm prospective
- Scope
Patient 18 – 80 y.o., with unruptured wide neck (neck ≥4 mm or dome:neck ratio ≤2), saccular, intracranial aneurysm, 4-20 mm diameter, treatable with LVIS™ or LVIS™ Jr.
- Purpose
Evaluate the safety and probable benefit of the Low-profile Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.) devices for the purpose of FDA humanitarian device exemption in the USA.
Endpoints
Effectiveness: Probable benefit measured by aneurysm angiographic occlusion of ≥ 90% at 6 months (assessed by Corelab)
Safety: Any major stroke or death within 30 days, or major ipsilateral stroke or neurological death within 6 months
Efficacy results
Technical success: 93.5%
Primary effectiveness endpoint result at 6 months: 92.9%
Complete occlusion at 6 months: 75.0%
Safety results
Primary safety endpoint event rate: 0% at 6 months
Patient mRS increase: 0% at 6 months
LINK TO STUDY PAGE ClinicalTrials.gov ID NCT01541254
Please refer to IFU for the full list of risks, contraindications, warnings, and precautions.
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