NCT02674672已完成不适用
A Safety and Efficacy Study for Implantation and Retrieval Procedures Using the VENATECH® Retrieval Filter System
B.Braun Médical - CoE Chasseneuil2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Safety and the efficacy of filter implantation and retrieval by the study of technical success rate of filter placement, and filter removal (when filter removal procedure is schedule) within 12 weeks of implantation
研究概览
简要总结
To establish the clinical safety and efficacy of the VenaTech® Retrievable Vena Cava Filter
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 thrombo-embolism with contraindication to anticoagulation.
- •Failure of anticoagulant therapy in thrombo-embolic diseases.
- •Prevention of pulmonary embolism in patients with a recent history ( <3 months) of DVT/ PE who need to undergo urgent surgery at high risk of DVT/PE with temporary contra-indication to the use of therapeutic doses of anticoagulants.
- •Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and
- •Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated
排除标准
- •The filter should not be implanted in patients with :
- •A vena cava which has a diameter < 14 mm or > 28 mm (due to the risk of device migration)
- •Risk of septic embolism
- •Known allergy to the materials contained in the kit, allergy to contrast media.
- •Severely disabled patients whose life-expectancy, up to 6 months, appears limited according to the investigator's opinion.
- •In addition, exclusion criteria are also extended to :
- •Patients who cannot be regularly followed up by the participating center
- •Subject who already has an implanted vena cava filter
- •Subject who has a duplicated IVC
- •Subject who has a contrast allergy to both iodinated contrast and non-iodinated contrast material
- •Subject unable to understand information about participation in the study due to a language barrier, intellectual deficiency, psychiatric problems...
- •Subject who has a renal failure (creatinemia clearance < 30ml/min)
结局指标
主要结局
Safety and the efficacy of filter implantation and retrieval by the study of technical success rate of filter placement, and filter removal (when filter removal procedure is schedule) within 12 weeks of implantation
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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