NCT00911417已完成4 期
The Jetstream G2 System Post-Market Peripheral Vascular IVUS Study
Pathway Medical Technologies Inc.10 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- Plaque Morphology
研究概览
简要总结
The Jetstream System is a commercially available rotating, aspirating, expandable catheter designed to remove atherosclerotic plaque and blood clots in the lower limbs. The purpose of this study is to use intravascular ultrasound (IVUS) during the interventional procedure to measure the amount of plaque and blood clots removed by the Jetstream System.
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
- •The patient is ≥ 18 years of age.
- •The documented peripheral vascular disease is/are located in a superficial femoral, popliteal or tibial peroneal trunk arteries in the lower limb.
- •The patient is an acceptable candidate for percutaneous intervention using the Jetstream G2 System in accordance with its labeled indications and instructions for use.
- •The patient has been informed about the nature of the study and has provided informed consent.
排除标准
- •Patient has no distal runoff.
- •Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
- •Patient is pregnant or nursing a child.
- •Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Jetstream G2 System.
- •Patient has clinically significant abnormal ECG or blood test results or any other factor that would put the patient at increased risk if participating in the study.
结局指标
主要结局
Plaque Morphology
时间窗: up to 12 month follow-up
次要结局
未报告次要终点
研究者
研究点 (10)
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