Evaluating a new embolization system for unruptured brain aneurysms
A SINGLE-ARM, OPEN LABEL, MULTI-CENTER EARLY FEASIBILITY STUDY OF THE LUSEED ANEURYSM EMBOLIZATION SYSTEM IN INDIVIDUALS WITH UPRUPTURED INTRACRANIAL ANEURYSMS
This study is testing a new device to see if it can safely treat unruptured brain aneurysms in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | LuSeed Vascular LTD. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 6 sites (Sofia and 5 other locations) |
| Trial ID | NCT06761365 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to assess the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms. It is a prospective, single-arm, open-label, multi-center study that will enroll up to 30 eligible patients across a maximum of 10 medical centers in the EU. Participants will be screened based on national or international guidelines and must meet specific inclusion and exclusion criteria to qualify for the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with unruptured intracranial aneurysms suitable for endovascular embolization.
Not a fit: Patients with ruptured intracranial aneurysms will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with unruptured intracranial aneurysms, potentially improving safety and outcomes.
How similar studies have performed: While this approach is being evaluated, similar studies have shown promise in the treatment of intracranial aneurysms using embolization techniques.
Eligibility criteria
Show full inclusion / exclusion 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 characteristics: * IA located in the anterior or posterior circulation * IA dimensions appropriate for treatment with LuSeed-Vascular Embolization Device per implant size selection guidelines as outlined in the Instructions for Use (IFU) and as follows: * IA Width: 2.5-5.5\[mm\] * IA Neck: 2.0-5.0\[mm\] * IA Height: min 4.0 \[mm\]- device short configuration, min 5.0 \[mm\]-device long configuration 4. Patient is willing and able to participate in the study for the duration of the study follow-up and can comply with study requirements Exclusion Criteria: 5. Patient able to give their informed consent can be included in this study. Exclusion Criteria 1. Ruptured intracranial aneurysm 2. Patient anatomy or physiology considered unsuitable for endovascular treatment as determined by imaging Core Lab 3. Contraindication for arterial access 4. Intracranial aneurysm neck diameter less than 2mm or greater than 5 mm 5. Intracranial aneurysm sac diameter less than 2.5mm or greater than 5.5mm 6. Intracarnial aneurysm minimum hight less than 4.0 mm 7. Target Intracranial aneurysm contains other devices/implants (e.g., coils) 8. Stenosis of the target IA's parent vessel \>50% 9. Known allergy to platinum, nickel, or titanium 10. Known allergy to contrast agents 11. Absolute contraindication to anticoagulation or antiplatelet therapy 12. Anticoagulation medications such as warfarin that cannot be discontinued 13. Pregnant, breastfeeding or planning pregnancy within next 12 months 14. Acute or chronic renal failure (stage III or IV by VARC-3 criteria) 15. Cerebral embolism, stroke, or TIA in past 6 months 16. Myocardial infarction in the past 6 months 17. Any other medical issue within the brain that would preclude device implantation (such as brain surgery, radiation in the target area of intervention from an external beam source, acute traumatic craniocerebral injury, etc.) 18. Patient had any circulatory, neurovascular, cardiovascular, or neurologic conditions that resulted in unstable neurological symptoms at screening. 19. Patient had physical, neurologic or psychiatric conditions which precluded his/her ability to comply with all aspects of the screening, evaluation, treatment, and the postprocedure follow-up schedule. 20. Other medical conditions that cause an inability to comply with study requirements and/or that could increase the risk of neurovascular procedures (e.g., extreme frailty, liver failure, cancer, heart failure, chronic obstructive pulmonary disease, immunosuppression, neural disease, and hematologic disorders etc.) 21. Patient had a life expectancy of less than 12 months . 22. Current participation in another study with investigational devices or drugs that would confound the effect of the study outcomes.
Where this trial is running
Sofia and 5 other locations
- University Hospital St. Ivan Rilski — Sofia, Bulgaria (Recruiting)
- The University Medical Center Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
- Sheba Medical Center — Tel Litwinsky, Israel (Recruiting)
- UCK Katowice — Katowice, Poland (Recruiting)
- Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz — Lodz, Poland (Recruiting)
- Jan Mikulicz-Radecki University Clinical Hospital in Wrocław — Wroclaw, Poland (Not_yet_recruiting)
Study contacts
- Principal investigator: Vitor Pereira, MD MSc
- Study coordinator: Nitzan Hirsh
- Email: Nitzan.h@luseed-vascular.com
- Phone: 972-545333200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.