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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Arterial Occlusive Diseases

Treatments: Radiation: dyna-pbv

Study type: Observational

Funder types: Other

Identifiers

NCT03248323

A03968

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients are diagnosed as lower limb atherosclerosis occlusion from June 2016 to June 2018 in our centre;
2. All participating patients provided written informed consent and willing to participate;
3. aged 40 years and more;
4. the class of lower ischemia is upon 4;
5. below-the-knee arteries stenosis or occlusion is indicated by duplex or computed tomographic angiography;
6. there is no heavy stenosis in superficial femoral artery (stenosis<30%), or short length lesion(length≤5cm, stenosis≥30%);
7. infection or ulceration don't happen in the area of surgery;
8. below the inguinal ligament arteries don't have the history of bypass or interventional surgery.

Exclusion criteria

1. disagree and refuse to the free therapy;
2. lesion length of superior artery is more than 5cm;
3. history of heart dysfunction: congestive heart failure,, myocardial infarction, severe arrhythmia;
4. With severe metabolic disease, renal impairment(serum creatinine>1.4mg/dL, glomerular filtration rate<60) affect the excretion of contrast agents;
5. have the diseases or agents which will reduce the viable of data;
6. allergy to iodinated contrast medium.

Trial design

120 participants in 1 patient group

pre-con

Treatment:

Radiation: dyna-pbv