Role of vascular inflammation in femoral popliteal artery lesions

Elucidation of the role of vascular inflammation in femoral popliteal artery lesions: an observational study using intravascular polarimetry with PS-OFDI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1052230165

Enrollment

Registered

2024-01-13

Start date

2024-01-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

LEAD inflammation, cell-free DNA, fibrosis, calcification

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Accelerated blood flow ratio (peak systolic velocity ratio (PSVR), patency on arterial ultrasound at 1year	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactKenichiro Otsuka

Osaka Metropolitan University Graduate School of Medicine

otsukakenichiro1@gmail.com+81-6-6645-3801

Outcome results