LUMENS-1 EU EFS CIP

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 prospective, single-arm, open-label, multi-center, interventional study, screening patients approved for treatment of unruptured IAs based on national or international guidelines. Up to 30 eligible subjects meeting inclusion and exclusion criteria and providing consent will be enrolled across a maximum of 10 medical centers in the EU.

NCT Number	NCT06761365
Lead Sponsor	LuSeed Vascular LTD.
Conditions	Aneurysm Cerebral, Bifurcation, Unruptured Intracranial Aneurysm, Saccular Aneurysm, Brain Aneurysm
Enrollment	30 participants
Start Date	2024-10-07
Primary Completion	2026-12 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2025-11-26