The Prism Trial: A Retrospective Case Review of Technical Success Using the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 5
- 主要终点
- Procedural Serious Adverse Events
研究概览
简要总结
The primary objective of this retrospective case review study is to determine the safety and effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of patients with confirmed peripheral or visceral arterial occlusion or embolus. This is a retrospective, single arm, multi-center trial. Up to 100 patients at up to 10 centers will be enrolled. Angiographic assessment of vessel patency at immediate post-procedure as measured by TIMI scores and procedural serious adverse events are assessed and recorded.
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
- •Evidence of a peripheral or visceral arterial occlusion or embolus (TIMI 0-1) prior to treatment.
- •Treatment with components of the Penumbra and/or Indigo System.
排除标准
- •Participation in another clinical investigation that may confound the results of the study.
研究组 & 干预措施
Mechanical thrombectomy by the Indigo System
干预措施: Mechanical Thrombectomy by the Indigo System (Device)
结局指标
主要结局
Procedural Serious Adverse Events
时间窗: During the procedure
Angiographic Assessment of Vessel Patency at Immediate Post-procedure as Measured by TIMI Scores
时间窗: Immediate post-procedure
Proportion of patients with a post-procedure TIMI score of 2 to 3.
次要结局
未报告次要终点