Prospective Comparison of Rigid Forceps Versus Endovascular Snare for Routine IVC Filter Retrieval
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Procedure related complications
研究概览
简要总结
IVC filters are mechanical filters placed in a patient's body to trap blood clots in the legs migrating to the lungs. When no longer indicated, interventional radiologists are consulted for IVC filter removal. Currently, many methods for extracting IVC filters exist. Two of the most common methods involve using an endovascular snare device or rigid forceps. We intend to prospectively compare these two methods in an attempt to see if one offers an advantage to the other. This will be compared by evaluating success rates and procedure time.
详细描述
Currently the optimal method for IVC filter retrieval with respect to success rate and fluoroscopic time (i.e. radiation exposure) is poorly understood. Both snare and forcep techniques have independently evaluated in literature but have never been compared directly. The proposed study would prospectively assess whether one of these established technique offers an advantage with respect to either of these variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
No masking
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
- •Non-pregnant females
- •Adult patients (age 18 years and older)
- •Referred to Interventional Radiology for IVC filter removal
- •IVC filter implanted less than 6 months with the procedure being performed at UCMC by current IR staff.
- •Cook Celect filter or Argon Medical Option Elite
排除标准
- •Patients with outside hospital filter placement
- •Filters other than Cook Celect or Argon Medical Option Elite
- •Implantation period >6 months
- •Evidence of coagulopathy (INR <1.8, platelet count >50k)
- •Clotting disorder
- •Central venous occlusion
- •Prior filter placement/removal.
研究组 & 干预措施
Forceps
Subjects randomized to this cohort will have their IVC filter removed using a rigid forceps device that will be used to engage the filter apex directly and allow for the filter to be capture/removed.
干预措施: IVC filter removal (Device)
Snare
Subjects randomized to this cohort will have their IVC filter removed using an endovascular snare (like a lasso) device that is designed to catch the hook of the filter and allow it to be captured.
干预措施: IVC filter removal (Device)
结局指标
主要结局
Procedure related complications
时间窗: Date of procedure through 6 months following IVC filter removal
After hemostasis is achieved, patients will be monitored for 2-4 hours in the interventional radiology recovery area. One month after filter retrieval, patients will be seen in clinic for follow-up. During this visit, a physicial assessment will done, including adverse events and review of medications. Six months after filter retrieval, patient will be contacted by telephone for follow-up. Adverse event and medication review will be performed during this call.
Flouroscopy time
时间窗: Procedure start to finish
Venography will be performed using a flush catheter and contrast material to evaluate for tip embedding. After filter retrieval, repeat venography will be performed to evaluate for thrombosis, caval spasm, caval perforation, fractured fragments, and other potential complications.
Removal success rate
时间窗: Procedure date
Data will be analyzed by a biostatistician to determine statistical differences between cohorts with respect to outcome measures.
Costs
时间窗: Date of procedure up through 6 months following IVC filter removal
Costs associated with filter removal encounter
次要结局
未报告次要终点