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.
LuSeed Vascular is sponsoring a prospective, multi-center single arm clinical trial enrollment initiated on October 2024 to assess early safety and feasibility of the LuSeed Aneurysm Embolization System for the treatment of unruptured intracranial aneurysms (IA).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
a permanent intrasaccular implant used for treatment of unruptured intracranial saccular aneurysms (IA) in adult patients according to international guidelines who are indicated for non-emergent endovascular embolization of saccular IAs at the time of presentation.
University Hospital St. Ivan Rilski
Sofia, Bulgaria
RECRUITINGThe University Medical Center Hamburg-Eppendorf
Hamburg, Germany
RECRUITINGSheba Medical Center
Tel Litwinsky, Israel
RECRUITINGUCK Katowice
Katowice, Poland
RECRUITINGNorbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz
Lodz, Poland
RECRUITINGJan Mikulicz-Radecki University Clinical Hospital in Wrocław
Wroclaw, Poland
NOT_YET_RECRUITINGPrimary Safety Endpoint
Death of any non-accidental cause, Procedure or Device Related Death or Any Major Disabling Stroke \*An independent Medical Monitor (IMM) will adjudicate all data used for safety endpoint analyses
Time frame: 30 Days Post Study Procedure
Primary Feasibility Endpoint
Technical Success as defined by: 1. Success in accessing target intracranial aneurysm (IA) with the LuSeed Aneurysm Embolization System 2. Successful visual confirmation of the LuSeed Aneurysm Embolization System Successful deployment and detachment of the LuSeed Aneurysm Embolization System
Time frame: Day 0
Secondary Safety Endpoints
Percentage of participants with death of non-accidental cause or device related death, or major disabling stroke at 6 months and 12 months.
Time frame: 12 months
Secondary Safety Endpoints
Percentage of participants presenting each component of the safety composite within first 30 days after treatment, 6 months and 12 months.
Time frame: 12 months
Secondary Safety Endpoints
Percentage of participants with serious adverse events within the first 30 days after treatment, 6 months and 12 months.
Time frame: 12 months
Secondary Effectiveness Endpoints
Proportion of subjects with Complete Aneurysm Occlusion immediate post procedure.
Time frame: 6-months and 12-months after treatment
Secondary Effectiveness Endpoints
Change in mRS between baseline.
Time frame: Day-30, 6-months, and 12-months
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