A Prospective Review of Excimer Laser Assisted Inferior Vena Cava (IVC) Filter Retrieval
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 535
- 试验地点
- 1
- 主要终点
- Evaluate any adverse events related to laser assisted IVC filter removal
研究概览
简要总结
This is a prospective chart review to follow our laser-assisted IVC filter retrieval patients. We intend to validate existing literature and scientific findings by publishing our own clinical experience in difficult IVC filter retrievals.
详细描述
At Northwestern Memorial Hospital in Chicago, IL USA, IVC filters are successfully removed >95%. Technical failures, although rare, are usually related to excessive endoluminal scarring at the point of IVC filter implantation. Adjunctive (or advanced) removal techniques are often employed in difficult cases. The excimer laser sheath has been successfully used at Northwestern for patients who had failed all other retrieval techniques.
Before a patient is to undergo an IVC filter removal using the Excimer Laser Sheath they will be consented to participate in the chart review study and become a part of a registry kept at Northwestern Memorial Hospital. The procedure itself is not being used as part of the study. Chart reviews will be completed and data collected on the procedure to remove the filter. Follow up after the procedure by phone call and chart review will be completed at least once, 1 week after the filter removal.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be male and female aged 18 years to 100 years old who were treated with either permanent or retrievable IVC filter placement and were referred to the Interventional Radiology or Vascular Surgery departments for IVC filter retrieval starting December 1,
- •Patients have failed all other traditional methods/attempts at removal of their IVC filter.
排除标准
- •Patients who refuse the use of the excimer laser device to attempt to remove their IVC filter.
结局指标
主要结局
Evaluate any adverse events related to laser assisted IVC filter removal
时间窗: up to 1 year after Laser Assited IVC filter removal
The number and severity of adverse events will be recorded to evaluate safety. This will be conducted as a phone call to the patient 1 week after IVC filter removal and then as a chart review only.
Effectiveness of Laser Assisted IVC filter removal
时间窗: At time of IVC filter removal
Success rate of removing IVC filters using the laser will be recorded. If a filter cannot be removed with the laser the reason for this failure will be recorded.
次要结局
未报告次要终点
研究者
Robert Lewandowski
Primary Investigator
Northwestern University