Actively Recruiting
LUMENS-1 EU EFS CIP
Led by LuSeed Vascular LTD. · Updated on 2025-11-26
30
Participants Needed
6
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
LUMENS-1 EU EFS CIP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients indicated for treatment of unruptured intracranial aneurysms according to AHA/ASA Guidelines
- Age between 18 and 80 years at screening
- Suitable for non-emergency endovascular embolization of saccular intracranial aneurysms
- Aneurysm located in anterior or posterior circulation
- Aneurysm dimensions appropriate for treatment with LuSeed device per instructions for use: Width 2.5-5.5 mm, Neck 2.0-5.0 mm, Height minimum 4.0 mm (short device) or 5.0 mm (long device)
- Willing and able to participate and comply with study requirements
- Able to give informed consent
You will not qualify if you...
- Ruptured intracranial aneurysm
- Anatomy or physiology unsuitable for endovascular treatment as determined by imaging Core Lab
- Contraindication for arterial access
- Aneurysm neck diameter less than 2 mm or greater than 5 mm
- Aneurysm sac diameter less than 2.5 mm or greater than 5.5 mm
- Aneurysm minimum height less than 4.0 mm
- Target aneurysm contains other devices or implants (e.g., coils)
- Stenosis of target aneurysm's parent vessel greater than 50%
- Known allergy to platinum, nickel, titanium, or contrast agents
- Absolute contraindication to anticoagulation or antiplatelet therapy
- Use of anticoagulation medications such as warfarin that cannot be discontinued
- Pregnant, breastfeeding, or planning pregnancy within 12 months
- Acute or chronic renal failure (stage III or IV by VARC-3 criteria)
- Cerebral embolism, stroke, or transient ischemic attack in past 6 months
- Myocardial infarction in past 6 months
- Other brain medical issues precluding device implantation (e.g., brain surgery, radiation, acute injury)
- Unstable neurological symptoms at screening due to circulatory, neurovascular, cardiovascular, or neurologic conditions
- Physical, neurologic, or psychiatric conditions preventing compliance with study procedures
- Other medical conditions increasing risk of neurovascular procedures or preventing compliance
- Life expectancy less than 12 months
- Current participation in another study with investigational devices or drugs that could affect outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
University Hospital St. Ivan Rilski
Sofia, Bulgaria
Actively Recruiting
2
The University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Actively Recruiting
3
Sheba Medical Center
Tel Litwinsky, Israel
Actively Recruiting
4
UCK Katowice
Katowice, Poland
Actively Recruiting
5
Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz
Lodz, Poland
Actively Recruiting
6
Jan Mikulicz-Radecki University Clinical Hospital in Wrocław
Wroclaw, Poland
Not Yet Recruiting
Research Team
N
Nitzan Hirsh
CONTACT
G
Gali Vino
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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