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

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ClinicalTrials.gov Identifier: NCT03248323
Recruitment Status : Unknown
Verified June 2016 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Arterial Occlusive Diseases Radiation: dyna-pbv

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
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
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

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



Primary Outcome Measures :
  1. patency rate [ Time Frame: 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 :
  1. wound healing rate [ Time Frame: 1 year ]
    This is to evaluate the prognosis of patients who with the foot ulcer.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248323


Contacts
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Contact: Bao Liu, Ph.D +86-010-69152502 liubao72@aliyun.com

Locations
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China
Peking Union Medical College Hospital Recruiting
Beijing, China
Contact: Yupei Zhao, Ph.D         
Sponsors and Collaborators
Peking Union Medical College Hospital
Additional Information:

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03248323    
Other Study ID Numbers: A03968
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: June 2016
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases