Merlin's DiVeRt-Vascular Reconstruction Device: a Prospective, Single Arm, Non-randomized, Open Label Study to Assess Safety and Performance
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Incidence of all serious adverse events assessed, clinically or angiographically
研究概览
简要总结
The objective of the proposed investigation is to assess the safety and effectiveness of the Merlin's DiVeRt system for the treatment of intracranial lesions.
Merlin is a manufacturer of Flow- Diverters (FD) for Neurovascular applications. The technology is based on a microporous polymer membrane which is delivered to the site of lesion treatment using a metal stent scaffold. The first device in its FD family is the XCalibur Aneurysm Occlusion Device (AOD) system, which is delivered on a rapid-exchange balloon catheter which goes in a 6-Fr guide-catheter. The AOD is CE-marked and has been involved in the treatment of over 70 clinical lesion/aneurysm cases. The same technology is now being made available in a self-expandable stent platform delivered on a 0.028" microcatheter. Merlin has performed the required in-silico, in-vitro and in-vivo tests to be confident of the device performance and now intends to proceed to the human clinical-trials. DiVeRt (Interventional) is a non CE mark device. The device is under clinical trial phase. The competent authority submission for the study has been completed in Spain, Turkey and Hungary.
详细描述
The study will recruit patients with intracranial aneurysm (IA) or a lesion located in the anterior or posterior circulation. The analyses of the data from this safety and feasibility study will be descriptive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
- •Age 18-80 years.
- •Subject has a target intracranial aneurysm (IA) or a lesion located in the anterior or posterior circulation.
- •Subject has a target IA with a wide or large neck aneurysm or a lesion. The aneurysm type includes saccular, fusiform, dissecting or blister shapes.
排除标准
- •Major surgery in the last 30 days.
- •History of irreversible bleeding disorder and/or subject presents with signs of active bleeding.
- •NIH Stroke Scale ( NIHSS) greater than or equal to 4
- •Any known contraindication to treatment with flow diverters.
- •Pregnant women.
- •Participating in another clinical trial.
结局指标
主要结局
Incidence of all serious adverse events assessed, clinically or angiographically
时间窗: 3 months
Serious Adverse events will be evaluated as device-related, procedure-related, or unrelated to the procedure or the device
Incidence of unsuccessful Divert placement
时间窗: 3 months
Incidence of unsuccessful Divert placement leading to, or with the potential of leading to, adverse events.
Aneurysm Occlusion Grading: MRRC scale
时间窗: 3 months
Evaluation of degree of aneurysm occlusion or degree of delayed opacification
次要结局
- In-stent stenosis (DSA)(6 months)