NCT00640731Unknown4 期
Study of the OmniWave Endovascular System in Subjects With Lower and Upper Extremity Deep Vein Thrombosis - SONIC I Study
OmniSonics Medical Technologies, Inc.0 个研究点目标入组 50 人开始时间: 2008年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 主要终点
- Procedural success rate defined as at least 50% reduction in thrombus burden in each target treatment zone following use of the OmniWave Endovascular System
研究概览
简要总结
This is a prospective, multi-center single arm registry to assess the use of the OmniWave Endovascular System in subjects presenting with either lower or upper extremity acute (symptoms have been present for greater than or equal to 14 days) DVT.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DVT confirmed by venographic and ultrasound imaging, which has been symptomatic for a maximum of 14 days, or diagnosed within past 14 days defined as either first episode (no prior history in affected segment), or recurrent episode.
- •Written informed consent
- •Agreement to comply with follow up requirements
排除标准
- •Known R-L shunt, pulmonary A-V malformation
- •Excessive tortuosity and/or sharp angulation in target treatment zone
- •Isolated calf vein thrombosis
- •Isolated DVT in veins peripheral to axillary vein
- •Thrombus in peripheral vessel smaller than 5 mm
- •Target treatment zone cannot be adequately accessed within the 100 cm working length of device
结局指标
主要结局
Procedural success rate defined as at least 50% reduction in thrombus burden in each target treatment zone following use of the OmniWave Endovascular System
时间窗: Post-Index procedure
次要结局
- Death, clinically detectable PE, significant vessel damage in target treatment area(through 6 months post-index procedure)
- Restoration and maintenance of antegrade in-line flow in target treatment area(through 6 months post-index procedure)
- QOL SF-36(through 6 months post-index procedure)
- Incidence of clinically significant hemolysis(Prior to discharge)
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