LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan (NCT07259018) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan
Canada10 participantsStarted 2025-12
Plain-language summary
The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms (IA). This is a single-arm, open-label, single-center, interventional study, screening patients approved for treatment of unruptured IAs based on national or international guidelines. Up to 10 eligible subjects meeting inclusion and exclusion criteria and providing consent will be enrolled in a Canadian site.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patients indicated for treatment of unruptured intracranial aneurysms (IA) according to AHA / ASA Guidelines.
✓. Age 18-80 years at screening
✓. Patients who are suitable for non-emergency endovascular embolization of saccular IAs
✓. The IA must have had the following characteristics:
✓. Patient is willing and able to participate in the study for the duration of the study follow-up and can comply with study requirements
✓. Patient able to give their informed consent can be included in this study.
Exclusion criteria
✕. Ruptured intracranial aneurysm
✕. Patient anatomy or physiology considered unsuitable for endovascular treatment as determined by imaging Core Lab
✕. Contraindication for arterial access
✕. Intracranial aneurysm neck diameter less than 2mm or greater than 5 mm
✕. Intracranial aneurysm sac diameter less than 2.5mm or greater than 5.5mm
✕. Intracranial aneurysm minimum height less than 4.0 mm
✕. Target Intracranial aneurysm contains other devices/implants (e.g., coils)