SEALANT Study:
LVIS™ Evo™ and HydroCoil® Embolic System for Intracranial Aneurysm Treatment
LVIS™ Evo™ and HydroCoil® Embolic System
"SEALANT provides robust prospective evidence supporting the safety and effectiveness of SAC using LVIS™ Evo™ and HES coils, in a population of predominantly wide-necked aneurysms."
- Patients
206
- Countries
Germany, France, UK, Italy and Belgium
- Clinical Centers
19
- Design
Single arm prospective
- Scope
Patients ≥ 18 y.o. with an unruptured or ruptured (> 30 days since occurrence) IC aneurysm requiring treatent with Stent assisted coiling with LVIS EVO and HES coils (90% in lenght).
- Purpose
Safety and efficacy evaluation of stent-assisted coiling procedures using LVIS™ Evo™ device with HES coils based on the morbidity and mortality rates and complete occlusion/ occlusion stability within 12 +/-6months after treatment
Endpoints
Aneurysm complete occlusion based on Raymond–Roy occlusion classification (RROC) at the 12 ± 6-month follow-up evaluated by an independent Core laboratory using digital subtraction angiograms (DSA).
Efficacy results
Successful implantation of LVIS EVO: 99.5%
Complete occlusion rate at 12±6 months using DSA: 82.1% (PP)
Retreatment at 12±6 months: 0.0%
Safety results
Primary safety endpoint: 2.4%
Major ipsilateral stroke or neurological death related to study devices or procedure: 1.0%
Intra procedural subarachnoid haemorrhage: 1.5%
In-stent thromboembolic complication:1.5%
Thromboembolic complication distal or proximal to the stent: 0.5%
Study publications
Coming soon
LINK TO STUDY PAGE: Clinical Trials NCT04999423
Please refer to IFU for the full list of risks, contraindications, warnings, and precautions.
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