A Prospective Study: the Value of Using iFlow and PBV in the Endovascular Treatment of Infrapopliteal Arterial Occlusive Diseases
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ClinicalTrials.gov Identifier: NCT03248323
Recruitment Status : Unknown
Verified June 2016 by Peking Union Medical College Hospital. Recruitment status was: Recruiting
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.
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
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.
Secondary Outcome Measures :
wound healing rate [ Time Frame: 1 year ]
This is to evaluate the prognosis of patients who with the foot ulcer.
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Layout table for eligibility information
Ages Eligible for Study:
40 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
These new technologies are performed in the treatment of patients older than 40 years. They present with rest pain, intermittent claudication, ulceration or gangrenous. Some of them have the risk factors of CLI, as hypertension, diabetes, hyperlipidemia or smoking. They are referred to our vascular service for CLI-infrapopliteal artery occlusion. Computed tomographic angiography discloses the occlusive lesion in anteriortibial, posterior tibial or peroneal arteries.
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.
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;