Hemodynamic Characteristics of Peripheral Arterial Disease Using Computational Fluid Dynamics

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Analysis of Hemodynamic Characteristics in Peripheral Arterial Disease Based on Computational Fluid Dynamics

Conditions

Peripheral Arterial Disease

Being tested

Computational Fluid Dynamics Simulation

Keywords

Computational Fluid Dynamics, Hemodynamics, Wall Shear Stress, Peripheral Vascular Resistance, Inlet velocity waveform amplitude

Medical subject headings

Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Computational Fluid Dynamics SimulationOther

  Patient-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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: During CFD simulation analysis, through January 2027

2. 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.

   Measured: During CFD simulation analysis, through January 2027

3. 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.

   Measured: During CFD simulation analysis, through January 2027

4. 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.

   Measured: During CFD simulation analysis, through January 2027

5. Transverse Wall Shear Stress (transWSS)

   Transverse wall shear stress (transWSS) will be derived from patient-specific computational fluid dynamics simulations of the lower-extremity arteries. transWSS will be evaluated across predefined inlet pulsatile velocity and distal peripheral resistance levels. Changes in transWSS across parameter levels and differences in hemodynamic responses between the PAD and control groups will be analyzed.

   Measured: During CFD simulation analysis, through January 2027

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Oct 2026
2. Study startNov 2026 (estimated)
3. Primary completionJan 2027 (estimated)
4. Study completionJan 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
• More trials run by Fudan UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.