LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan

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.

NCT Number	NCT07259018
Lead Sponsor	LuSeed Vascular LTD.
Conditions	Aneurysm Cerebral, Bifurcation, Unruptured Intracranial Aneurysm, Saccular Aneurysm, Brain Aneurysm
Enrollment	10 participants
Start Date	2025-12
Primary Completion	2027-12 (estimated)
Study Completion	2028-05 (estimated)
Updated on ClinicalTrials.gov	2025-12-09