Chronic Limb-Threatening Ischemia, Critical Limb Ischemia, Peripheral Arterial Disease
Conditions
Keywords
Tissue perfusion, Peripheral arterial disease, Critical limb threatening ischemia, Critical limb ischemia, Fluorescence angiography, Fluorescence imaging, Indocyanine green, Microcirculation
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.
Interventions
PROCEDURERevascularization
Open surgery (arterial endarterectomy with or without bypass surgery) and/or angioplasty (with or without stent placement)
Sponsors
Medical University Innsbruck
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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 |
Countries
Austria
Contacts
Primary ContactFlorian K Enzmann, MD, PhD
Backup ContactMichaela Kluckner, MD
Outcome results
None listed