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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03248323
Enrollment
120
Registered
2017-08-14
Start date
2016-06-30
Completion date
2019-06-30
Last updated
2017-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Occlusive Diseases

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.

Interventions

RADIATIONdyna-pbv

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
patency rate1 yearWe 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

MeasureTime frameDescription
wound healing rate1 yearThis is to evaluate the prognosis of patients who with the foot ulcer.

Countries

China

Contacts

Primary ContactBao Liu, Ph.D
liubao72@aliyun.com+86-010-69152502

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026