A Prospective Study: the Value of Using Parametric Color Coding of Digital Subtraction Angiography and Flat-panel Detector Computed Tomography Parenchymal Blood Volume Imaging in the Endovascular Treatment of Infrapopliteal Arterial Occlusive Diseases
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- patency rate
研究概览
简要总结
Color coded blood flow and blood perfusion techniques are applied to the endovascular treatment of infrapopliteal arterial occlusion,to establish a method of quantitative evaluation of blood flow and tissue perfusion,to improve the level of calculation of condition and curative effect. So as to establish a new complete evaluation system of infrapopliteal arterial occlusive disease, to guide clinical further. At the same time establish a digital information platform for clinical, lay the foundation for the large research.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are diagnosed as lower limb atherosclerosis occlusion from June 2016 to June 2018 in our centre;
- •All participating patients provided written informed consent and willing to participate;
- •aged 40 years and more;
- •the class of lower ischemia is upon 4;
- •below-the-knee arteries stenosis or occlusion is indicated by duplex or computed tomographic angiography;
- •there is no heavy stenosis in superficial femoral artery (stenosis<30%), or short length lesion(length≤5cm, stenosis≥30%);
- •infection or ulceration don't happen in the area of surgery;
- •below the inguinal ligament arteries don't have the history of bypass or interventional surgery.
排除标准
- •disagree and refuse to the free therapy;
- •lesion length of superior artery is more than 5cm;
- •history of heart dysfunction: congestive heart failure,, myocardial infarction, severe arrhythmia;
- •With severe metabolic disease, renal impairment(serum creatinine>1.4mg/dL, glomerular filtration rate<60) affect the excretion of contrast agents;
- •have the diseases or agents which will reduce the viable of data;
- •allergy to iodinated contrast medium.
结局指标
主要结局
patency rate
时间窗: 1 year
We compare the change of blood flow velocity and blood perfusion volume before and after the recanalization of infrapopliteal arteries to assess the initial patency rate. While we test the ankle brachial index and toe brachial index at 3 , 6, 12 months, lower extremity arterial ultrasound at 6 mouths and computed tomographic angiography in 1 year to evaluate the patency of one year.
次要结局
- wound healing rate(1 year)