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

Recruiting

• Conditions: Peripheral Arterial Disease; Critical Limb Ischemia; Chronic Limb-Threatening Ischemia

• Registration Number: NCT05570019
• Lead Sponsor: Medical University Innsbruck

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2022-08-29
• Study Start: 2022-10-01
• Study First Submitted QC: 2022-10-03
• Study First Posted: 2022-10-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transcutaneous oxygen pressure	Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure	Change in transcutaneous oxygen pressure is measured before and after the revascularization procedure.

Secondary Outcome Measures

Name	Time	Method
Secondary patency	Post-procedural (within 5 days) and 3 months after the index procedure	Secondary patency of the treated arterial lesion is documented after the procedure
Fluorescence angiography	Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure	Change in fluorescence angiography is documented before and after the revascularization procedure.
Survival	Post-procedural (within 5 days) and 3 months after the index procedure	Survival of patients after the revascularization.
Primary patency	Post-procedural (within 5 days) and 3 months after the index procedure	Primary patency of the treated arterial lesion is documented after the procedure
Ankle-brachial index (ABI)	Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure	Change in ABI is documented before and after the revascularization procedure.
Rutherford category	Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure	Change in Rutherford category is documented before and after the revascularization procedure.
Limb salvage	Post-procedural (within 5 days) and 3 months after the index procedure	Limb salvage of the treated extremity is documented after the procedure
WIfI stage	Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure	Change in WIfI (wound, ischemia, foot infection) stage is documented before and after the revascularization procedure.

Trial Locations

Locations (1)

Department of Vascular Surgery, Medical University Innsbruck; 🇦🇹 Innsbruck, Tyrol, Austria