SMART - A Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL® System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 995
- 试验地点
- 141
- 主要终点
- Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout
研究概览
简要总结
The primary objective of this study is to gather post market data on the Penumbra SMART COIL® System (Smart System) in the treatment of intracranial aneurysms and other malformations.
详细描述
This is a prospective, multi-center registry of patients treated in accordance with the cleared indications for the Smart System (Smart), Penumbra Coil 400TM (PC 400), and Penumbra Occlusion Device (POD®). Data for each patient are collected in accordance with the standard of care at each participating hospital through one-year follow-up. Approximately 1,000 patients with intracranial aneurysms or other malformations treated by the Smart System at up to 100 centers will be enrolled. It is anticipated patient enrollment will take 3 years. All patients are to be assessed in accordance with the standard of care at each participating hospital through one year follow-up.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients enrolled in this study must sign the Informed Consent Form and be treated according to the cleared indications for the Smart, PC 400, and POD, which include the embolization of:
- •Intracranial aneurysms
- •Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
排除标准
- •Life expectancy less than one year
- •Smart, PC 400, or POD account for less than 75% of total number of coils implanted
- •Participation in another clinical investigation that could confound the evaluation of the registry device
结局指标
主要结局
Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout
时间窗: Immediate Post Procedure
Re-access attempts due to catheter kick-out across all coils
Number of Participants Achieving Adequate Occlusion Immediate Post Procedure
时间窗: Immediate Post Procedure
Based on investigator's adjudication of adequate occlusion given anatomical and other considerations immediate post-procedure.
Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure
时间窗: Immediate Post Procedure
Number of Participants Requiring Retreatment Through Follow-up
时间窗: One year from enrollment
次要结局
未报告次要终点