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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Tissue Perfusion in Patients With Lower Extremity Peripheral Arterial Disease

Conditions
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Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Critical Limb Ischemia

Intervention / Treatment
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* Procedure: Revascularization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Revascularization|Open surgery (arterial endarterectomy with or without bypass surgery) and/or angioplasty (with or without stent placement)|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tissue perfusion, Peripheral arterial disease, Critical limb threatening ischemia, Critical limb ischemia, Fluorescence angiography, Fluorescence imaging, Indocyanine green, Microcirculation