About this trial
Peripheral arterial disease can reduce blood flow to the legs. This study will examine how blood flow patterns in the leg arteries differ between people with peripheral arterial disease and people without the disease.
Researchers will use existing computed tomography angiography (CTA) images and medical records from participants who previously received CTA as part of routine clinical care. Three-dimensional models of the leg arteries will be created from these images. Computer simulations will then be used to study how changes in blood flow entering the arteries and resistance in smaller downstream blood vessels affect blood flow patterns. The researchers will compare these responses between participants with and without peripheral arterial disease.
This study uses only existing medical records and images. No new participants will be recruited, and no additional examinations or treatments will be performed for research purposes. The goal is to better understand blood flow characteristics associated with peripheral arterial disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Participants who underwent lower-extremity computed tomography angiography (CTA).
PAD group: Diagnosis of lower-extremity peripheral artery disease (PAD), defined by a resting ankle-brachial index (ABI) ≤0.90.
PAD group: For participants in whom ABI was inconclusive, including ABI >0.90 or ABI >1.40 due to medial arterial calcification, PAD was confirmed by lower-extremity CTA or Doppler ultrasound showing ≥50% arterial stenosis or complete occlusion.
Disqualifiers
History of lower-extremity arterial revascularization.
Presence of other diseases that could substantially affect lower-extremity hemodynamics.
CTA image quality insufficient for three-dimensional vascular reconstruction.
Trial population
Adults who underwent lower-extremity computed tomography angiography (CTA) between January 1 and December 31, 2025, and met the eligibility criteria for either the peripheral artery disease (PAD) group or the healthy control group were retrospectively included. One patient-specific bilateral lower-extremity arterial computational fluid dynamics (CFD) model was constructed for each participant, and each participant and corresponding vascular model were treated as one independent study unit.
Trial design
Case-control
Retrospective
Treatments tested in this trial
Computational Fluid Dynamics Simulation
Other interventionPatient-specific three-dimensional lower-extremity arterial models will be reconstructed from existing CTA images and analyzed using computational fluid dynamics (CFD). Two independent single-factor simulation experiments will be performed: an inlet velocity experiment, in which the amplitude of the inlet pulsatile velocity waveform is varied while distal peripheral resistance is held constant, and a peripheral resistance experiment, in which distal peripheral resistance is varied while inlet velocity is held constant. These simulations are performed only on computational models and do not involve any clinical intervention, additional examination, or treatment of participants.
Treatment groups
Trial outcomes
Primary outcomes
Time-Averaged Wall Shear Stress (TAWSS)
Time-averaged wall shear stress (TAWSS) will be derived from patient-specific computational fluid dynamics simulations of the lower-extremity arteries. TAWSS will be evaluated across predefined inlet pulsatile velocity and distal peripheral resistance levels. Changes in TAWSS across parameter levels and differences in hemodynamic responses between the PAD and control groups will be analyzed.
Oscillatory Shear Index (OSI)
Oscillatory shear index (OSI) will be derived from patient-specific computational fluid dynamics simulations of the lower-extremity arteries. OSI will be evaluated across predefined inlet pulsatile velocity and distal peripheral resistance levels. Changes in OSI across parameter levels and differences in hemodynamic responses between the PAD and control groups will be analyzed.
Relative Residence Time (RRT)
Relative residence time (RRT) will be derived from patient-specific computational fluid dynamics simulations of the lower-extremity arteries. RRT will be evaluated across predefined inlet pulsatile velocity and distal peripheral resistance levels. Changes in RRT across parameter levels and differences in hemodynamic responses between the PAD and control groups will be analyzed.
Endothelial Cell Activation Potential (ECAP)
Endothelial cell activation potential (ECAP) will be derived from patient-specific computational fluid dynamics simulations of the lower-extremity arteries. ECAP will be evaluated across predefined inlet pulsatile velocity and distal peripheral resistance levels. Changes in ECAP across parameter levels and differences in hemodynamic responses between the PAD and control groups will be analyzed.
Secondary outcomes
Hemodynamic Response of Time-Averaged Wall Shear Stress (TAWSS) to Changes in Distal Peripheral Resistance
Time-averaged wall shear stress (TAWSS) will be evaluated across predefined levels of distal peripheral resistance. Inlet pulsatile velocity will be held constant during the peripheral resistance experiment. Changes in TAWSS across distal peripheral resistance levels and differences in response patterns between the PAD and control groups will be analyzed.
Hemodynamic Response of Oscillatory Shear Index (OSI) to Changes in Distal Peripheral Resistance
Oscillatory shear index (OSI) will be evaluated across predefined levels of distal peripheral resistance. Inlet pulsatile velocity will be held constant during the peripheral resistance experiment. Changes in OSI across distal peripheral resistance levels and differences in response patterns between the PAD and control groups will be analyzed.
Hemodynamic Response of Relative Residence Time (RRT) to Changes in Distal Peripheral Resistance
Relative residence time (RRT) will be evaluated across predefined levels of distal peripheral resistance. Inlet pulsatile velocity will be held constant during the peripheral resistance experiment. Changes in RRT across distal peripheral resistance levels and differences in response patterns between the PAD and control groups will be analyzed.
Hemodynamic Response of Endothelial Cell Activation Potential (ECAP) to Changes in Distal Peripheral Resistance
Endothelial cell activation potential (ECAP) will be evaluated across predefined levels of distal peripheral resistance. Inlet pulsatile velocity will be held constant during the peripheral resistance experiment. Changes in ECAP across distal peripheral resistance levels and differences in response patterns between the PAD and control groups will be analyzed.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: