Prospective Randomized Evaluation of the Denali and Option Inferior Vena Cava Filters
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- IVC: Filter Penetration
研究概览
简要总结
This research study is a prospective randomized trial evaluating the relative safety of two inferior vena cava (IVC) filters used to prevent the migration of potentially dangerous deadly blood clots from the legs to the lung in patients who cannot take blood thinners. All eligible patients will have been ordered to have a IVC filter placed by their primary medical team and filters will be placed in these patients whether or not they wish to participate in this trial as part of standard of care. The investigators will follow up with patients 30 days after IVC filter placement and ask them to come back for filter removal if medically appropriate. If removal is not medically appropriate in 30 days, the investigators will attempt to schedule removal every 30 days after initial placement.
Primary outcome measures will be IVC filter complications such as filter penetration through the IVC wall and into other organs, filter tilt, filter migration, filter fracture and clots formed within the filter. All of these are reported complications of all IVC filters.
The research also aims to improve the standard of care for IVC filter patient follow up as the FDA and Society of Interventional Radiology recommend that IVC filters be removed as soon as it is safe to do so.
Hypothesis:
The investigators hypothesize that there is no significant difference in efficacy and complication rate between the Option and the Denali filter.
详细描述
This is a prospective, randomized trial comparing two FDA-approved inferior vena cava filters, the Denali retrievable IVC filter (Bard Peripheral Vascular Inc., Tempe, AZ) and the Option Elite (Argon Medical, Athens, Texas).
Patients scheduled for IVC filter placement at UCSF Department of Interventional Radiology (IR) will be asked by the IR physician performing the procedure at either UCSF Mt. Zion or Moffitt hospital if they wish to participate in this prospective, randomized study. Recruitment will be conducted by the physicians performing the IR procedures only. No additional recruitment calls, emails, posters or web pages are necessary. All procedures and the randomization to one of the two experimental groups will be carefully explained before obtaining signed written consent.
Screening:
Screening will be conducted by the IR physician prior to the placement of the IVC filters. Since this is a standard of care study, patients who are recommended for IVC filter placement and are scheduled for the procedure are generally eligible.
The screening procedures are part of routine care before IVC filter placement and would be done even if patients did not join the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
analysis of the imaging data will be masked and filter type and PHI will be redacted so the radiologist assessor will not know which patients receive either the option or denali..
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
- •Patients scheduled for IVC filter placement at UCSF Moffitt, Mission Bay and Mount Zion hospitals Interventional Radiology
排除标准
- •Necessity of permanent IVC filter.
- •Genetic or physical abnormalities of the inferior vena cava
- •Circumstances that in the opinion of the primary investigator, patient would be a poor candidate either due to complications in medical condition or lack of ability for follow up.
研究组 & 干预措施
Denali
Denali IVC Filter
干预措施: Filter Placed (Device)
Option
Option Elite IVC Filter
干预措施: Filter Placed (Device)
结局指标
主要结局
IVC: Filter Penetration
时间窗: in dwelling time in 1 day after filter insertion up to 3 years.
Using imaging analysis, patients will resume their standard care as normal but be encouraged to come back in 30 days for imaging followup and removal. other than that we will look at all available CT and xray imaging that clearly shows the filter and IVC vessel walls. We will count how many participants have penetration of the IVC greater than 3mm and the number of days since placement at imaging timepoints. The number of struts or hooks per filter with penetration will also be recorded.
次要结局
- IVC Filter Improved Patient Follow Up and Prompt Filter Removal(Number of participants who had filters removed after 30 days up to 1 year)
- Computerized Tomography (CT) Studies With IVC Penetration(0-1733 days)
- IVC Filter Improved Patient Follow Up and Prompt Filter Removal: Number of Days(Number of participants who had filters removed after 30 days up to 1 year)
- IVC Filter Tilt(0-365 days post placement until project closure or patient endpoint reached)
- IVC Filter Clot(30 days)
- Number of Participants With IVC Filter Migration(30 days)
- IVC Filter Fracture(30 days)