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Role of vascular inflammation in femoral popliteal artery lesions

Not Applicable
Conditions
EAD
inflammation, cell-free DNA, fibrosis, calcification
Registration Number
JPRN-jRCT1052230165
Lead Sponsor
Fukuda Daiju
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
50
Inclusion Criteria

1. The person is 20 years of age or older at the time of obtaining consent for the first time.
2. Have symptoms of atherosclerosis or peripheral artery disease.
3. Ankle brachial index (ABI) at rest is 0.90 or less.
ABI is 0.91 or higher with a decrease of 20 mmHg or more in ankle systolic blood pressure during exercise load or a decrease of 20% or more of ABI or skin reflux pressure less than 60 mmHg.

Exclusion Criteria

1. thrombus on raw angiography in the target lesion
2. congestive heart failure
3. cases with a general condition that the doctor deems inappropriate

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Accelerated blood flow ratio (peak systolic velocity ratio (PSVR), patency on arterial ultrasound at 1year
Secondary Outcome Measures
NameTimeMethod
Correlation between cfDNA concentration and PS-OFDI findings (birefringence) in the lesion area and the following parameters; symptoms (Rutherford classification), ABI, date of last follow-up, presence or absence of survival, date of last confirmation of patency, date of confirmation of stenosis, occlusionDate of confirmation, date of target lesion revascularization (TLR), date of target vessel revascularization (TVR), date of acute occlusion, target vessel bypass surgery date, affected limb revascularization date, affected limb major amputation date
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