Evaluation of Perfusion and Oxygenation in Muscle of Patients With PAD Undergoing LER
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 55
- 主要终点
- MSOT Multispectral Optoacoustic Tomography,
研究概览
简要总结
During this IIT, the MSOT (Multispectral Optoacoustic Tomography ) Acuity Echo will be used to scan participants with Peripheral Arterial Disease assess MSOT Multispectral Optoacoustic Tomography (single-wavelength and hemoglobin-related parameters) in the Tibialis Anterior, and flexor hallucis brevis, at multiple time-points before, during and after interventional Lower Extremity Revascularization (LER ).
Primary aim of the study ist the Comparison of the difference between oxygenated, deoxygenated hemoglobin and oxygenation in the tibialis anterior, and flexor hallucis brevis, at multiple time-points before, during and after interventional Lower Extremity Revascularization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •• Written consent of the participant after being informed
- •Adults above 18 years
- •Participants with PAD stage 4 - 6 (Rutherford) with indication for interventional LER
排除标准
- •• Participants with previous LER on the same leg
- •Participants less than 18years
- •Pregnancy
- •Participants with tattoos in the scan area
- •Participants with no clinical indication for interventional LER
- •Missing consent form
结局指标
主要结局
MSOT Multispectral Optoacoustic Tomography,
时间窗: baseline pre LER, 30 minutes post LER, 24 hours post LER, 48hours post LER
single-wavelength, HbT, Hb, HbO2, collagen and mSO2 (700-1.100 nm wavelength range, in 10 nm increments) in the tibialis anterior and flexor hallucis brevis, at multiple time-points before, during and after interventional LER Lower Extremity Revascularization .
次要结局
未报告次要终点