A Prospective Study: the Value of Using iFlow and PBV in the Endovascular Treatment of Infrapopliteal Arterial Occlusive Diseases

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Arterial Occlusive Diseases

Intervention / Treatment
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* Radiation: dyna-pbv


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pre-con<br> | Radiation: dyna-pbv<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patency rate | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing rate | This is to evaluate the prognosis of patients who with the foot ulcer. | 1 year |