NCT03898869Unknown不适用
Measurement of Revascularization Effect Using Near Infrared Spectroscopy in Below the Knee Arteries
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Increase in oxygen amount sufficient for wound healing
研究概览
简要总结
Patient with occluded below the knee arteries and chronic limb ischemia Rutherford class V-VI are enrolled.
During endovascular recanalisation procedure changes in tissue oxygen amount is recorded using near infrared spectroscopy (NIRS).
Primary hypothesis - NIRS can be used to determine sufficient amount of blood reaching the ulcered ishemic area.
Secondary hypothesis - NIRS can be useful in detecting early recoil after BTK recanalisation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critical limb ischemia Rutherford V-VI
- •At least one artery below the knee is planned to revascularize
排除标准
- •Blood oxygen saturation below 85% because of any comorbidities
- •Life expectancy less than 12 months
- •Unavoidable amputation above ankle
- •Skin diseases preventing the use of NIRS
结局指标
主要结局
Increase in oxygen amount sufficient for wound healing
时间窗: 12 months
次要结局
- Detection of early recoil after BTK revascularization(1 hour)
研究者
Tomas Baltrūnas
Tomas Baltrūnas
Vilnius University
研究点 (1)
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