Role of vascular inflammation in femoral popliteal artery lesions

JRCT ID: jRCT1052230165

Registered date:13/01/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: LEAD
• Date of first enrollment: 13/01/2024
• Target sample size: 50
• Study type: Observational

Outcome(s)

• Primary Outcome: Accelerated blood flow ratio (peak systolic velocity ratio (PSVR), patency on arterial ultrasound at 1year
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Fukuda Daiju