Evaluation of Tissue Perfusion in Peripheral Arterial Disease (EVTI-PAD)

Last updated: March 12, 2024
Sponsor: Medical University Innsbruck
Overall Status: Active - Recruiting

Phase

N/A

Condition

Peripheral Arterial Occlusive Disease

Claudication

Vascular Diseases

Treatment

Revascularization

Clinical Study ID

NCT05570019
1440/2021
  • Ages > 18
  • All Genders

Study Summary

In this prospective single-center observational study, arterial perfusion in patients with lower limb peripheral arterial disease will be assessed with standard diagnostic tools (toe pressure, trans-cutaneous oxygen pressure, ankle-brachial index and fluorescence angiography) before and after standard revascularization procedures (open surgery and/or angioplasty).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients with symptomatic peripheral arterial disease (Rutherford categories 3-6)requiring revascularization.

Exclusion

Exclusion Criteria:

  • patients younger than 18 years
  • patients unable to give consent without legal guardians
  • iodine allergy
  • hyperthyroidism
  • allergy to indocyanine green
  • Glomerular filtration rate <30ml/min/1.73m2

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Revascularization
Phase:
Study Start date:
October 01, 2022
Estimated Completion Date:
December 31, 2024

Study Description

Arterial perfusion is an important parameter for the capacity of wound healing in patients with peripheral arterial disease (PAD). Quantifying tissue perfusion in affected patients can help in deciding whether further revascularization is necessary to achieve wound healing and limb salvage. Not only in PAD patients with ulceration, but also in patients with rest pain or life-style limiting claudication, the measurement of arterial perfusion before and after revascularization could influence further treatment regarding surgical/interventional procedures as well as medical treatment. Digital subtraction angiography (DSA) is the gold standard for the evaluation of peripheral arterial outflow and for quality assessment after revascularization. However, angiography only displays the larger arteries and not tissue perfusion itself, which is crucial for wound healing. In this study, the change of tissue perfusion measured with the different standard diagnostic tools (toe pressure, trans-cutaneous oxygen pressure, ankle-brachial index and fluorescence angiography) before and after standard revascularization procedures will be evaluated.

Connect with a study center

  • Department of Vascular Surgery, Medical University Innsbruck

    Innsbruck, Tyrol 6020
    Austria

    Active - Recruiting

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