Hemodynamic Characteristics of Peripheral Arterial Disease Using Computational Fluid Dynamics

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Other: Computational Fluid Dynamics Simulation

• Study Type: Observational
• Enrollment (Estimated): 14

Contacts and Locations

• Study Contact: Name: Wan Zhang, MD, PhD; Phone Number: 021-62483180-571401; Email: ant0930@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Huadong Hospital, Fudan University
      • Contact: Wan Zhang, MD, PhD; Phone Number: 021-62483180-571401; Email: ant0930@163.com
      • Principal Investigator: Wan Zhang, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.
• Control group: No symptoms suggestive of lower-extremity ischemia and no definite evidence of lower-extremity arterial stenosis or occlusion on CTA; ABI was used when necessary to further exclude PAD.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: CASE_CONTROL
• Time Perspectives: RETROSPECTIVE

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PAD Group; Participants with a clinical diagnosis of lower-extremity peripheral arterial disease and available lower-extremity CTA images suitable for patient-specific three-dimensional arterial reconstruction.	Other: Computational Fluid Dynamics Simulation; 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.
Control Group; Participants without clinical evidence of peripheral arterial disease or significant lower-extremity arterial stenosis and with CTA images suitable for patient-specific three-dimensional arterial reconstruction.	Other: Computational Fluid Dynamics Simulation; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During CFD simulation analysis, through January 2027
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.	During CFD simulation analysis, through January 2027
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.	During CFD simulation analysis, through January 2027
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.	During CFD simulation analysis, through January 2027
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.	During CFD simulation analysis, through January 2027

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During CFD simulation analysis, through January 2027
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.	During CFD simulation analysis, through January 2027
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.	During CFD simulation analysis, through January 2027
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.	During CFD simulation analysis, through January 2027
Hemodynamic Response of Transverse Wall Shear Stress (transWSS) to Changes in Distal Peripheral Resistance	Transverse wall shear stress (transWSS) will be evaluated across predefined levels of distal peripheral resistance. Inlet pulsatile velocity will be held constant during the peripheral resistance experiment. Changes in transWSS across distal peripheral resistance levels and differences in response patterns between the PAD and control groups will be analyzed.	During CFD simulation analysis, through January 2027
Interaction Between Study Group and Hemodynamic Parameter Level for Time-Averaged Wall Shear Stress (TAWSS)	Group-by-parameter-level interactions will be evaluated for time-averaged wall shear stress (TAWSS) to determine whether the TAWSS response to changes in inlet pulsatile velocity or distal peripheral resistance differs between the PAD and control groups.	During CFD simulation analysis, through January 2027
Interaction Between Study Group and Hemodynamic Parameter Level for Oscillatory Shear Index (OSI)	Group-by-parameter-level interactions will be evaluated for oscillatory shear index (OSI) to determine whether the OSI response to changes in inlet pulsatile velocity or distal peripheral resistance differs between the PAD and control groups.	During CFD simulation analysis, through January 2027
Interaction Between Study Group and Hemodynamic Parameter Level for Relative Residence Time (RRT)	Group-by-parameter-level interactions will be evaluated for relative residence time (RRT) to determine whether the RRT response to changes in inlet pulsatile velocity or distal peripheral resistance differs between the PAD and control groups.	During CFD simulation analysis, through January 2027
Interaction Between Study Group and Hemodynamic Parameter Level for Endothelial Cell Activation Potential (ECAP)	Group-by-parameter-level interactions will be evaluated for endothelial cell activation potential (ECAP) to determine whether the ECAP response to changes in inlet pulsatile velocity or distal peripheral resistance differs between the PAD and control groups.	During CFD simulation analysis, through January 2027
Interaction Between Study Group and Hemodynamic Parameter Level for Transverse Wall Shear Stress (transWSS)	Group-by-parameter-level interactions will be evaluated for transverse wall shear stress (transWSS) to determine whether the transWSS response to changes in inlet pulsatile velocity or distal peripheral resistance differs between the PAD and control groups.	During CFD simulation analysis, through January 2027
Hemodynamic Response of Time-Averaged Wall Shear Stress (TAWSS) to Changes in Inlet Pulsatile Velocity	Time-averaged wall shear stress (TAWSS) will be evaluated across predefined levels of inlet pulsatile velocity while distal peripheral resistance is held constant. Changes in TAWSS across inlet pulsatile velocity levels and differences in response patterns between the PAD and control groups will be analyzed.	During CFD simulation analysis, through January 2027
Hemodynamic Response of Oscillatory Shear Index (OSI) to Changes in Inlet Pulsatile Velocity	Oscillatory shear index (OSI) will be evaluated across predefined levels of inlet pulsatile velocity while distal peripheral resistance is held constant. Changes in OSI across inlet pulsatile velocity levels and differences in response patterns between the PAD and control groups will be analyzed.	During CFD simulation analysis, through January 2027
Hemodynamic Response of Relative Residence Time (RRT) to Changes in Inlet Pulsatile Velocity	Relative residence time (RRT) will be evaluated across predefined levels of inlet pulsatile velocity while distal peripheral resistance is held constant. Changes in RRT across inlet pulsatile velocity levels and differences in response patterns between the PAD and control groups will be analyzed.	During CFD simulation analysis, through January 2027
Hemodynamic Response of Endothelial Cell Activation Potential (ECAP) to Changes in Inlet Pulsatile Velocity	Endothelial cell activation potential (ECAP) will be evaluated across predefined levels of inlet pulsatile velocity while distal peripheral resistance is held constant. Changes in ECAP across inlet pulsatile velocity levels and differences in response patterns between the PAD and control groups will be analyzed.	During CFD simulation analysis, through January 2027
Hemodynamic Response of Transverse Wall Shear Stress (transWSS) to Changes in Inlet Pulsatile Velocity	Transverse wall shear stress (transWSS) will be evaluated across predefined levels of inlet pulsatile velocity while distal peripheral resistance is held constant. Changes in transWSS across inlet pulsatile velocity levels and differences in response patterns between the PAD and control groups will be analyzed.	During CFD simulation analysis, through January 2027

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Wan Zhang, MD, PhD, Huadong Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: September 28, 2026
• First Submitted That Met QC Criteria: October 2, 2026
• First Posted (Actual): October 6, 2026

Study Record Updates

• Last Update Posted (Actual): October 6, 2026
• Last Update Submitted That Met QC Criteria: October 2, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Hemodynamics; Peripheral Vascular Resistance; Computational Fluid Dynamics; Wall Shear Stress; Inlet velocity waveform amplitude
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 2026K387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No