A SINGLE-ARM, OPEN LABEL, MULTI-CENTER EARLY FEASIBILITY STUDY OF THE LUSEED ANEURYSM EMBOLIZATION SYSTEM IN INDIVIDUALS WITH UPRUPTURED INTRACRANIAL ANEURYSMS
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aneurysm Cerebral
- Sponsor
- LuSeed Vascular LTD.
- Enrollment
- 30
- Locations
- 6
- Primary Endpoint
- Primary Safety Endpoint
- Status
- Recruiting
- Last Updated
- 5 months ago
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 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).
Investigators
Eligibility Criteria
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 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
Exclusion Criteria
- •Patient able to give their informed consent can be included in this study. 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
- •Intracarnial aneurysm minimum hight 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
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: 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 Outcomes
- Secondary Safety Endpoints(12 months)
- Secondary Effectiveness Endpoints(Day-30, 6-months, and 12-months)