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

Arterial Occlusive Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03248323
• Other study ID #: A03968
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2017
• Last updated: August 11, 2017
• Start date: June 2016
• Est. completion date: June 2019

Study information

• Verified date: June 2016
• Source: Peking Union Medical College Hospital
• Contact: Bao Liu, Ph.D
• Phone: +86-010-69152502
• Email: liubao72[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases

Intervention

Radiation:
• dyna-pbv

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	wound healing rate	This is to evaluate the prognosis of patients who with the foot ulcer.	1 year