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NCT Number: NCT06645353

Evaluation of Perfusion and Oxygenation in Muscle of Patients With PAD Undergoing LER

During this IIT, the MSOT (Multispectral Optoacoustic Tomography ) Acuity Echo will be used to scan participants with Peripheral Arterial Disease assess MSOT Multispectral Optoacoustic Tomography (single-wavelength and hemoglobin-related parameters) in the Tibialis Anterior, and flexor hallucis brevis, at multiple time-points before, during and after interventional Lower Extremity Revascularization (LER ).

Primary aim of the study ist the Comparison of the difference between oxygenated, deoxygenated hemoglobin and oxygenation in the tibialis anterior, and flexor hallucis brevis, at multiple time-points before, during and after interventional Lower Extremity Revascularization.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Written consent of the participant after being informed
  • Adults above 18 years
  • Participants with PAD stage 4 - 6 (Rutherford) with indication for interventional LER

Exclusion criteria

  • • Participants with previous LER on the same leg
  • Participants less than 18years
  • Pregnancy
  • Participants with tattoos in the scan area
  • Participants with no clinical indication for interventional LER
  • Missing consent form

Treatment and study plan

MSOT Multispectral Optoacoustic Tomography

Device

MSOT Multispectral Optoacoustic Tomography, single-wavelength, HbT, Hb, HbO2, collagen and mSO2 (700-1.100 nm wavelength range, in 10 nm increments) in the tibialis anterior and flexor hallucis brevis, at multiple time-points before, during and after interventional LER Lower Extremity Revascularization .

Primary outcomes

  1. MSOT Multispectral Optoacoustic Tomography,

    Time frame: baseline pre LER, 30 minutes post LER, 24 hours post LER, 48hours post LER

    single-wavelength, HbT, Hb, HbO2, collagen and mSO2 (700-1.100 nm wavelength range, in 10 nm increments) in the tibialis anterior and flexor hallucis brevis, at multiple time-points before, during and after interventional LER Lower Extremity Revascularization .

Study contacts

Contact information is provided by the study sponsor or research team.

Astrid Friedel

CONTACT

[email protected]

031638578017

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • iThera Medical GmbH

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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