LUMENS-1 EU EFS CIP

Recruiting N/A Interventional Study
Aneurysm Cerebral Bifurcation Unruptured Intracranial Aneurysm Saccular Aneurysm Brain Aneurysm
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
LuSeed Vascular LTD. · Industry
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About This Trial
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 elig…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients indicated for treatment of unruptured intracranial aneurysms (IA) according to AHA / ASA Guidelines. 1. Age 18-80 years at screening 2. Patients who are suitable for non-emergency endovascular embolization of saccular IAs 3. The IA must have had the following c…
Contacts

Nitzan Hirsh

972-545333200

Nitzan.h@luseed-vascular.com

CONTACT

Gali Vino

972525527565

galiv@luseed-vascular.com

CONTACT