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

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.

Study Overview

• Status: Unknown
• Conditions: Arterial Occlusive Diseases
• Intervention / Treatment: Radiation: dyna-pbv

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Bao Liu, Ph.D; Phone Number: +86-010-69152502; Email: liubao72@aliyun.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Yupei Zhao, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pre-con	Radiation: dyna-pbv

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound healing rate	This is to evaluate the prognosis of patients who with the foot ulcer.	1 year

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Publications and helpful links

General Publications

• Shao J, Ma J, Lai Z, Yu X, Li K, Xu L, Chen J, Wang C, Cao W, Liu X, Yuan J, Liu B. Impaired pedal arch affects the treatment effect in patients with single tibial artery revascularization demonstrated by intraoperative perfusion. Quant Imaging Med Surg. 2022 Jun;12(6):3204-3212. doi: 10.21037/qims-21-801.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: August 11, 2017
• First Posted (Actual): August 14, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2017
• Last Update Submitted That Met QC Criteria: August 11, 2017
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: A03968