Retrievability and Incidence of Complex Retrieval in Celect Versus Denali Filter: A Prospective, Randomized, Comparative Study
试验速览
- 阶段
- 不适用
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Incidence of complicated filter retrieval
研究概览
简要总结
The primary purpose of this study is to compare the Celect and Denali filters in terms of complicated filter retrieval and indwelling complications after a 2-month indwelling time.
详细描述
With anticoagulation being the standard treatment for deep venous thrombosis and pulmonary embolism, inferior vena cava filter placement plays an important role in patients who are amenable to anticoagulant therapy. Currently, many different types of retrievable filters are being used in clinical practice and the choice of the filters depends on operators' preference and institutional availability. Each filter has different designs to maximize retrievability and minimize indwelling complications. Up until now, the prior studies on the filter retrievability and indwelling complications have been retrospective in nature and had relatively long dwell times. Comparative data regarding the retrievability of the inferior vena cava filters may help to choose filter selection. Therefore, the aim of this trial is to compare two commonly used inferior vena cava filters (Denali and Celet filters)
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 (Participant)
盲法说明
Participants are blinded to the filter type.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who develop deep venous thrombosis and/or pulmonary embolism but are good candidates for anticoagulant therapy
- •Inferior vena cava filtration before mechanical thrombectomy for deep venous thrombosis
- •Prophylactic filter placement because of trauma or major surgery
排除标准
- •Those who need permanent filter placement
- •Congenital anatomical anomaly (IVC duplication, interrupted IVC)
- •patients who need filter placement in the suprarenal inferior vena cava
研究组 & 干预措施
Denali Group
Those who received Denali filter placement
干预措施: Infrarenal vena cava filter placement (Device)
Celect Group
Those who received Celect filter placement
干预措施: Infrarenal vena cava filter placement (Device)
结局指标
主要结局
Incidence of complicated filter retrieval
时间窗: 2 months after filter placement
Incidence of retrieval cases that require the use of standard retrieval kit (sheath and snare)
次要结局
- Incidence of penetration(2 months after filter placement)
- Filter migration(2 months after filter placement)
- tilt angle(2 months after filter placement)
- fracture(2 months after filter placement)
- signs of inferior vena cava occlusion/stenosis(2 months after filter placement)