NCT00233740已完成4 期
The Cordis Protection From Pulmonary Embolism With the Permanent OptEase™ Filter - A Post Marketing Surveillance Study (PROOF Study)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- The co-primary endpoints are migration of the OptEase™ IVC filter as determined by abdominal x-ray at 1-month post-implantation and symptomatic thrombosis at 1-month post-implantation. Migration is defined as > 2 cm movement in either cranial or caudal
研究概览
简要总结
The main objective of this study is to monitor the safety and effectiveness of the OptEase™ Permanent Vena Cava (IVC) Filter
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
- Treatment
- 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
- •· Pulmonary thromboembolism when anticoagulants are contraindicated.
- •Failure of anticoagulant therapy in thromboembolic diseases.
- •Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.
- •Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
排除标准
- •· Patients with risk of septic embolism.
- •Patients with uncontrolled infectious disease.
- •Patients with an IVC diameter > 30 mm.
- •Patients contraindicated for procedures under fluoroscopy.
- •Patients with demonstrated hypersensitivity to one or more of the components of the OptEase™ filter
结局指标
主要结局
The co-primary endpoints are migration of the OptEase™ IVC filter as determined by abdominal x-ray at 1-month post-implantation and symptomatic thrombosis at 1-month post-implantation. Migration is defined as > 2 cm movement in either cranial or caudal
次要结局
- To assess major adverse event rates related to the filter or filter procedure, up to 6-month follow-up, in aggregate and individually. Major adverse events are defined as 1) death, 2) pulmonary embolism, 3) symptomatic thrombosis, 4) caval penetration
- To assess the longer-term stability of the filter defined by the lack of migration as seen on abdominal x-ray at 6-month post-implantation. Migration is defined as > 2 cm movement in either cranial or caudal direction as seen on abdominal x-ray compar
- To assess the clinical success of the filter up to 6-month follow-up. Clinical success is defined as the absence of symptomatic pulmonary embolism (PE) evaluated clinically at post-implantation, 1- and 6-months post-implantation.
- To assess the technical success of the filter up to 6-month follow-up. Technical success is defined as the filter successfully deployed at the intended site in the IVC with the correct orientation.
- To assess significant tilting (> 15° off the axis of the IVC) up to 6-month follow-up.
- To assess filter fracture up to 6-month follow-up.
- Procedure-related bleeding (defined as requiring transfusion or > 3 gm decrease in hemoglobin).
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