Aneurysm Cerebral, Bifurcation, Brain Aneurysm, Saccular Aneurysm, Unruptured Intracranial Aneurysm
Conditions
Brief 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 single-arm, open-label, single-center, interventional study, screening patients approved for treatment of unruptured IAs based on national or international guidelines. Up to 10 eligible subjects meeting inclusion and exclusion criteria and providing consent will be enrolled in a Canadian site.
Detailed description
LuSeed Vascular will sponsor the study and the study will assess early safety and feasibility of the LuSeed Aneurysm Embolization System for the treatment of unruptured intracranial aneurysms (IA).
Interventions
LuSeed Aneurysm Embolization System EFS Canada
Sponsors
LuSeed Vascular LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients indicated for treatment of unruptured intracranial aneurysms (IA) according to AHA / ASA Guidelines. 2. Age 18-80 years at screening 3. Patients who are suitable for non-emergency endovascular embolization of saccular IAs 4. The IA must have had the following characteristics: * IA located in bifurcation 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 • The AI must meet the definition of a wide-neck aneurysm. 5. Patient is willing and able to participate in the study for the duration of the study follow-up and can comply with study requirements 6. 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. Intracranial aneurysm minimum height 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | 30 Days Post Study Procedure | Death of any non-accidental cause, Procedure or Device Related Death or Any Major Disabling Stroke \*An independent Medical Monitor (IMM) will adjudicate all data used for safety endpoint analyses |
| Primary Feasibility Endpoint | Day 0 | Technical Success as defined by: a. Success in accessing target intracranial aneurysm (IA) with the LuSeed Aneurysm Embolization System b. Successful visual confirmation of the LuSeed Aneurysm Embolization System Successful deployment and detachment of the LuSeed Aneurysm Embolization System |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety Endpoints | 12 months | Percentage of participants with death of non-accidental cause or device related death, or major disabling stroke at 6 months and 12 months. |
| Secondary Effectiveness Endpoints | 6-months and 12-months after treatment | Proportion of subjects with Complete Aneurysm Occlusion immediate post procedure. |
Countries
Canada
Contacts
Primary ContactNitzan Hirsh
Backup ContactGali Vino
Outcome results
None listed