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

NCT ID: NCT03248323

Last Updated: 2017-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Arterial Occlusive Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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pre-con

dyna-pbv

Intervention Type RADIATION

Interventions

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dyna-pbv

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bao Liu, Ph.D

Role: CONTACT

+86-010-69152502

Facility Contacts

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Yupei Zhao, Ph.D

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35655837 (View on PubMed)

Other Identifiers

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A03968

Identifier Type: -

Identifier Source: org_study_id

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