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

NCT03248323 | Unknown

• 1 other identifier: A03968
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Occlusive Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• wound healing rate

  1 year

Study Arms (1)

pre-con

Radiation: dyna-pbv

Interventions

dyna-pbv RADIATION

pre-con

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35655837 DERIVED

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Bao Liu, Ph.D

CONTACT

+86-010-69152502; liubao72@aliyun.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: August 14, 2017
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: August 14, 2017

Record last verified: 2016-06

Locations

CN (1)