Evaluation of Safety and Performance of the Neuroform AtlasTM Stent System for Intracranial Aneurysm Treatment - Post Market Clinical Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 11
- 主要终点
- permanent morbidity rate defined as any major ipsilateral stroke or neurolgocial death within 12 to 16 months following the procedure
研究概览
简要总结
The primary objective of this study is to demonstrate effectiveness and safety of the NeuroForm Atlas stent system for use in patients requiring stent assisted intracranial aneurysm treatment.
详细描述
The study is a prospective, multicenter, open-label, single arm post market follow-up registry designed to demonstrate the potential treatment of intracranial, saccular aneurysms with the Next Generation Neuroform Stent System. The study will evaluate the permanent morbidity and mortality rate within the 12 to 16 months following the procedure. The study will evaluate as well the percent occlusion of the treated target lesion on angiography in the absence of retreatment, or parent artery stenosis at the target location at 12 to 16 months. Subjects with documented saccular aneurysms arising from a parent artery may potentially benefit from stent assisted coiling, provided they meet the other eligibility criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has an intracranial aneurysm for which an endovascular treatment requiring stent assisted intracranial aneurysm coiling has been decided by the site investigator
- •Patient or legal representative is willing and able to provide written informed consent
- •Patient is willing able to comply with scheduled visits and examinations per protocol requirements
排除标准
- •Patient that is younger than 18 years old at the time of entry into the study
- •Patient with mRS > 3
- •Patient has a saccular ruptured aneurysm < 3 months
- •Patient has a fusiform aneurysm
- •Treatment of several aneurysms during the same procedure, except adjacent aneurysms treated with the same stent
- •Planned treatment of other aneurysm in the same vascular territory within the study time period
- •Patient with severe vasospasm that does not respond to pharmacological therapy
- •Aneurysm associated with an arteriovenous malformation, or any other lesion that could lead to hemorrhagic complications
- •Pregnant woman or child feeding
- •Any condition which will not allow the patient to comply with the necessary follow-up for this study (medical condition, patient leaving abroad)
- •Patient with confirmed allergy to nickel titanium (Nitinol)
- •Patient in whom antiplatelet and/or anticoagulation therapy is contraindicate
- •Patient for whom angiography and other examinations show that access to the target cerebral aneurysm by the stent may be impossible because of anatomical features
- •Patient for whom angiography and MRA/MRI is contraindicated
- •Patient with target aneurysm previously treated with a stent -
结局指标
主要结局
permanent morbidity rate defined as any major ipsilateral stroke or neurolgocial death within 12 to 16 months following the procedure
时间窗: 16 Months
mortality rate within 12 to 16 months following the procedure
时间窗: 16 Months
次要结局
- Subarachnoid hemorrhage rate(16 months)
- New or worsening major ipsilateral stroke as measured by NIHSS and mRS(16 months)
- Complete aneurysm occlusion rate of the treated target lesion on 16 month imaging(16 months)
- Aneurysm Rupture rate(16 months)