NCT02725307已完成不适用
Non-invasive Peri- and Postoperative Monitoring of Femoral Artery Balloon Angioplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pulse wave change from baseline during PTA
研究概览
简要总结
This study evaluates a novel noninvasive method to dynamically monitor the effect of percutaneous transluminal angioplasty on arterial pulse wave
详细描述
Patients with stenosis of superficial femoral artery referred for percutaneous transluminal angioplasty are monitored before, during and after the procedure and pulse wave analysis is conducted.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has been clinically examined at policlinic of vascular surgery
- •The patient has undergone measurement of ankle-brachial index (ABI) and toe-brachial index (TBI) at policlinic of vascular surgery and exhibits abnormal ABI<0.9 or ABI>1.3
- •The patient is considered to have an indication for vascular procedure (critical limb ischemia, intermittent claudication)
- •The patient has been examined with magnetic resonance imaging (MRA)
- •The patient has been considered a candidate for superficial femoral artery percutaneous transluminal balloon angioplasty (PTA) and/or stenting
排除标准
- •Measurement disturbs or risks the subject's treatment process
- •Withdrawal:
- •Emergency cases
- •By subject's denial
- •Inability to detect signals -
结局指标
主要结局
Pulse wave change from baseline during PTA
时间窗: 1 hour
次要结局
- Pulse wave characteristics after PTA(30 days)
研究者
Niku Oksala
Associate Professor (Tenure track)
Tampere University Hospital
研究点 (1)
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