A SINGLE-ARM, OPEN LABEL, MULTI-CENTER EARLY FEASIBILITY STUDY OF THE LUSEED ANEURYSM EMBOLIZATION SYSTEM IN INDIVIDUALS WITH UPRUPTURED INTRACRANIAL ANEURYSMS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 9
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Patient is willing and able to participate in the study for the duration of the study follow-up and can comply with study requirements
排除标准
- •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
- •Known allergy to contrast agents
- •Absolute contraindication to anticoagulation or antiplatelet therapy
- •Anticoagulation medications such as warfarin that cannot be discontinued
- •Pregnant, breastfeeding or planning pregnancy within next 12 months
- •Acute or chronic renal failure (stage III or IV by VARC-3 criteria)
- •Cerebral embolism, stroke, or TIA in past 6 months
- •Myocardial infarction in the past 6 months
- •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.)
- •Patient had any circulatory, neurovascular, cardiovascular, or neurologic conditions that resulted in unstable neurological symptoms at screening.
- •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.
- •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.)
- •Patient had a life expectancy of less than 12 months .
- •Current participation in another study with investigational devices or drugs that would confound the effect of the study outcomes.
结局指标
主要结局
Primary Safety Endpoint
时间窗: 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
时间窗: 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
次要结局
- Secondary Effectiveness Endpoints(Day-30, 6-months, and 12-months)
- Secondary Safety Endpoints(12 months)