A Single-arm, Open Label, Single-center Early Feasibility Study of the LuSeed Aneurysm Embolization System in Individuals With Unruptured Intracranial Aneurysms.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- LuSeed Vascular LTD.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Primary Safety Endpoint
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients indicated for treatment of unruptured intracranial aneurysms (IA) according to AHA / ASA Guidelines.
- •Age 18-80 years at screening
- •Patients who are suitable for non-emergency endovascular embolization of saccular IAs
- •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.
Exclusion Criteria
- •Ruptured intracranial aneurysm
- •Patient anatomy or physiology considered unsuitable for endovascular treatment as determined by imaging Core Lab
- •Contraindication for arterial access
- •Intracranial aneurysm neck diameter less than 2mm or greater than 5 mm
- •Intracranial aneurysm sac diameter less than 2.5mm or greater than 5.5mm
- •Intracranial aneurysm minimum height less than 4.0 mm
- •Target Intracranial aneurysm contains other devices/implants (e.g., coils)
- •Stenosis of the target IA's parent vessel \>50%
- •Known allergy to platinum, nickel, or titanium
- •Known allergy to contrast agents
Outcomes
Primary Outcomes
Primary Safety Endpoint
Time Frame: 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
Time Frame: 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 Outcomes
- Secondary Safety Endpoints(12 months)
- Secondary Effectiveness Endpoints(Day-30, 6-months and 12-months)