Difficult aneurysms for endovascular treatment: overwide or undertall?
W Brinjikji, H J Cloft, D F Kallmes
https://pubmed.ncbi.nlm.nih.gov/19461057Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06761365
A Single-Arm, Open-Label, Multi-Center Early Feasibility Study of the LuSeed Aneurysm Embolization System in Adults with Unruptured Intracranial Saccular Aneurysms
Led by LuSeed Vascular LTD. · Updated on 2025-11-26
30
Participants Needed
6
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms (IA). This prospective, single-arm, open-label, multi-center study will enroll up to 30 adults aged 18 to 80 who are approved for treatment under national or international guidelines. The trial aims to gather initial data on this device for non-emergency embolization of saccular IAs. Participants will receive treatment using the LuSeed Aneurysm Embolization System, a permanent implant designed for unruptured intracranial saccular aneurysms. The device is used in patients whose aneurysms meet specific size and location criteria, following guidelines for safe implantation. The study includes a single treatment attempt with this device and does not include a comparison group. Throughout the study, participants will be closely monitored with safety assessments at 30 days post-procedure and follow-ups extending to 12 months. Researchers will evaluate both safety and effectiveness outcomes at multiple time points including 6 and 12 months after treatment. Participants must be able to comply with all study visits and follow-up requirements, which include imaging and clinical evaluations to assess the device's performance and any adverse effects.
CONDITIONS
Brief Title
LUMENS-1 EU EFS CIP
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years at screening
- Patients indicated for treatment of unruptured intracranial aneurysms according to AHA / ASA Guidelines
- 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 implant size guidelines (Width 2.5-5.5 mm, Neck 2.0-5.0 mm, Height minimum 4.0 mm for short device configuration or 5.0 mm for long configuration)
- Willing and able to participate and comply with study follow-up 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 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, or titanium
- Known allergy to contrast agents
- Absolute contraindication to anticoagulation or antiplatelet therapy
- Anticoagulation medications like warfarin that cannot be stopped
- Pregnant, breastfeeding, or planning pregnancy within 12 months
- Acute or chronic renal failure (stage III or IV)
- Cerebral embolism, stroke, or TIA in past 6 months
- Myocardial infarction in past 6 months
- Other brain medical issues precluding device implantation (e.g., brain surgery, radiation, trauma)
- Unstable neurological symptoms from circulatory, neurovascular, cardiovascular, or neurologic conditions
- Physical, neurologic, or psychiatric conditions preventing compliance with study
- Other medical conditions increasing neurovascular procedure risk (e.g., frailty, liver failure, cancer)
- Life expectancy less than 12 months
- Current participation in another investigational device or drug study that may affect outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day 0
Participants receive the LuSeed Aneurysm Embolization System, a permanent intrasaccular implant for treatment of unruptured intracranial saccular aneurysms.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - 12 months
Participants are monitored for safety and effectiveness after device implantation.
Visits at Day 30, 6 months, and 12 months (in-person)
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
Loading map...
Research Team
N
Nitzan Hirsh
G
Gali Vino
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
An overview of intracranial aneurysms.
Alexander Keedy
https://pubmed.ncbi.nlm.nih.gov/18523626