Blood Flow Quantification Near Stented SFA Lesions Using Ultrasound Velocimetry

Last updated: June 21, 2021
Sponsor: Rijnstate Hospital
Overall Status: Completed

Phase

N/A

Condition

Claudication

Vascular Diseases

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT04934501
2018-1206
  • Ages > 18
  • All Genders

Study Summary

Peripheral arterial disease (PAD) in the lower extremity is the third leading cause of atherosclerotic cardiovascular morbidity. Endovascular treatment has become the principal surgical strategy in femoro-popliteal lesions. Stent placement induces significant changes in the arterial geometry and thereby in the hemodynamic environment. Visualization of local blood flow patterns (around stents) is challenging, but clinically relevant. Blood flow has a significant influence on the development of atherosclerosis and therefore stent patency. In vivo blood flow characterization might enable the recognition, prediction and explanation of (in-stent) restenosis. This study will therefore aim to investigate the feasibility of a novel ultrasound technique (echoPIV) to quantify spatiotemporal blood flow near stented femoral artery lesions. Furthermore, the blood flow information obtained during the echoPIV measurements will be used as patient-specific boundary conditions in a computational fluid dynamics (CFD) simulation. The tested hypothesis is that blood flow quantification using echoPIV is feasible in and around stents in the femoral artery and that it will improve CFD simulations.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Scheduled endovascular treatment of a lesion in the SFA through placement of a baremetal or a covered stent
  • A recently (<6 weeks) treated lesion in the SFA through placement of a bare metal or acovered stent

Exclusion

Exclusion Criteria:

  • Hypersensitivity to the active substance(s) or any of the excipients in SonoVue
  • Right-to-left cardiac shunt
  • Severe pulmonary hypertension (pulmonary artery pressure > 90mmHg)
  • Uncontrolled systemic hypertension
  • Adult respiratory distress syndrome
  • Severe pulmonary disease (e.g. COPD GOLD 3/4, adult respiratory distress syndrome)
  • Clinically unstable cardiac disease (recent or ongoing myocardial infarction, unstableangina at rest, recent percutaneous coronary intervention, clinically worseningcardiac symptoms, severe cardiac arrythmia's, endocarditis, etc.)
  • Prosthetic valves
  • Loss of renal function (GFR < 31 ml/min), end-stage renal disease
  • End-stage liver disease Sepsis
  • Hypercoagulable status, recent thrombosis
  • Congestive heart failure (class III or IV)
  • Hypersensitivity to iodinated contrast media
  • Pregnancy

Study Design

Total Participants: 20
Study Start date:
August 08, 2018
Estimated Completion Date:
August 30, 2019

Connect with a study center

  • Rijnstate Hospital

    Arnhem, Gelderland
    Netherlands

    Site Not Available

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