NCT00605332已完成2 期
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System - ("Retrieve")
Crux Biomedical0 个研究点目标入组 88 人开始时间: 2007年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 主要终点
- Primary Efficacy Objective: To describe the clinical utility of the Crux IVCF by the following criteria: Absence of a recurrent PE and IVC thrombosis related to the Crux IVCF.
研究概览
简要总结
This is an open label, non-randomized, prospective, multicenter study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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 for this study must meet the following inclusion criteria to be eligible for enrollment:
- •The patient is >18 years of age.
- •Patient is considered a candidate for the IVCF under one of the following indications:
- •Proven PE
- •Recurrent PE despite adequate anticoagulation
- •Contraindication to anticoagulation
- •Inability to achieve/maintain therapeutic anticoagulation
- •Iliocaval DVT
- •Large, free-floating proximal (i.e. ileofemoral) DVT
- •Massive PE treated with thrombolysis/thrombectomy
- •Chronic PE treated with thrombectomy
- •Protection during thrombolysis for iliocaval DVT
- •PE with limited cardiopulmonary reserve
- •Poor compliance with anticoagulant medications
- •High risk of injury worsened by anticoagulation (e.g., ataxia, falls)
- •Multi-trauma patient with high risk of PE
- •Surgical patients at high risk of PE
- •Medical condition with high risk of PE
- •Patient has a vena cava diameter of 17-28mm.
- •The patient or legal guardian has been informed of the nature of the study and agrees to its provisions and has provided informed written consent.
- •The patient is willing to be available for the appropriate follow-up for the duration of the study.
- •The patient has suitable IVC anatomy that would allow infra-renal placement of the filter.
排除标准
- •Patients who have ANY of the following exclusion criteria are NOT eligible for the study:
- •The patient has one of the following conditions:
- •Renal vein thrombosis
- •IVC thrombosis extending to renal veins
- •Duplicate IVC
- •Gonadal vein thrombosis
- •Requires supra-renal filter placement
- •The patient has an uncontrolled infectious disease.
- •The patient is at risk for aseptic PE.
- •Patient has uncontrollable coagulopathy.
- •Patient has an existing IVCF.
- •The patient has a life expectancy of less than 6 months.
- •The patient is pregnant.
- •The patient has a condition that inhibits radiographic visualization of the IVC.
- •The patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol.
- •The patient has a known hypersensitivity to contrast which cannot be pre-treated.
- •The patient's access vessels preclude safe insertion of the delivery system.
- •The patient is participating in another device or drug study. Patient must have completed the follow- up phase of any previous study at least 30 days prior to enrollment into this trial. The patient may only be enrolled in this study once.
- •The patient is unable and/or unwilling to cooperate with study procedures or required follow-up visits.
结局指标
主要结局
Primary Efficacy Objective: To describe the clinical utility of the Crux IVCF by the following criteria: Absence of a recurrent PE and IVC thrombosis related to the Crux IVCF.
时间窗: 30 days post implant, 30 days post retrieval. Patients with indwelling filters will return 1 and 6 months post implant procedure.
次要结局
- Primary Safety Objective: To estimate the proportion of patients who experience device/procedure related complications associated with the Crux IVCF.(30 days post implant procedure and 30 days post retrieval procedure. Patients with indwelling filters will return 1 and 6 months post implant procedure.)
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