Clinical Research Directory
Browse clinical research sites, groups, and studies.
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 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.
Official title: A SINGLE-ARM, OPEN LABEL, MULTI-CENTER EARLY FEASIBILITY STUDY OF THE LUSEED ANEURYSM EMBOLIZATION SYSTEM IN INDIVIDUALS WITH UPRUPTURED INTRACRANIAL ANEURYSMS
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-10-07
Completion Date
2027-06
Last Updated
2025-11-26
Healthy Volunteers
No
Conditions
Interventions
LuSeed Aneurysm Embolization System
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.
Locations (6)
University Hospital St. Ivan Rilski
Sofia, Bulgaria
The University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Sheba Medical Center
Tel Litwinsky, Israel
UCK Katowice
Katowice, Poland
Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz
Lodz, Poland
Jan Mikulicz-Radecki University Clinical Hospital in Wrocław
Wroclaw, Poland