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

• Conditions: Arterial Occlusive Diseases
• Interventions: Radiation: dyna-pbv

• Registration Number: NCT03248323
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-08-11
• Last Update Submitted: 2017-08-11
• Study First Posted: 2017-08-14
• Last Update Posted: 2017-08-14
• Primary Completion: 2018-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pre-con	dyna-pbv	-

Primary Outcome Measures

Name	Time	Method
patency rate	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.

Secondary Outcome Measures

Name	Time	Method
wound healing rate	1 year	This is to evaluate the prognosis of patients who with the foot ulcer.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China