Aneurysm Cerebral, Bifurcation, Brain Aneurysm, Saccular Aneurysm, Unruptured Intracranial Aneurysm
Conditions
Keywords
Bifurcation, Embolization, Flow Diverter, Intrasaccular Device, Cerebral Aneurysm, Unruptured
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 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.
Detailed description
LuSeed Vascular is sponsoring a prospective, multi-center single arm clinical trial enrollment initiated on October 2024 to assess early safety and feasibility of the LuSeed Aneurysm Embolization System for the treatment of unruptured intracranial aneurysms (IA).
Interventions
a permanent intrasaccular implant used for treatment of unruptured intracranial saccular aneurysms (IA) in adult patients according to international guidelines who are indicated for non-emergent endovascular embolization of saccular IAs at the time of presentation.
Sponsors
LuSeed Vascular LTD.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
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: 1. Success in accessing target intracranial aneurysm (IA) with the LuSeed Aneurysm Embolization System 2. 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
Bulgaria, Germany, Israel, Poland
Contacts
Primary ContactNitzan Hirsh
Backup ContactGali Vino
Outcome results
None listed