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Starting soon Observational

Hemodynamic Characteristics of Peripheral Arterial Disease Using Computational Fluid Dynamics

NCT07860138 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2026-11
Last updated
2026-10-06

Condition(s) studied

Peripheral Arterial Disease

Investigational drug(s) / intervention(s)

Computational Fluid Dynamics Simulation

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.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Time-Averaged Wall Shear Stress (TAWSS) — During CFD simulation analysis, through January 2027
    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) — During CFD simulation analysis, through January 2027
    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) — During CFD simulation analysis, through January 2027
    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) — During CFD simulation analysis, through January 2027
    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.
  • Transverse Wall Shear Stress (transWSS) — During CFD simulation analysis, through January 2027
    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.

Trial sites (1)

FacilityCityRegionStatus
Huadong Hospital, Fudan University Shanghai Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07860138 on ClinicalTrials.gov ↗ ← All trials in China