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

NCT06645353 | Not Yet Recruiting

• 1 other identifier: MSOT
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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 .

  baseline pre LER, 30 minutes post LER, 24 hours post LER, 48hours post LER

Interventions

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 .

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

• Participants with PAD stage 4 - 6 (Rutherford) with indication for interventional LER

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• iThera Medical GmbH: collaborator

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Astrid Friedel

CONTACT

031638578017; astrid.friedel@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 16, 2024
• Study Start: November 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share