Evaluation of Tissue Perfusion in Patients With Lower Extremity Peripheral Arterial Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Medical University Innsbruck
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Transcutaneous oxygen pressure
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Transcutaneous oxygen pressure
Time Frame: 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 Outcomes
- Secondary patency(Post-procedural (within 5 days) and 3 months after the index procedure)
- Fluorescence angiography(Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure)
- Survival(Post-procedural (within 5 days) and 3 months after the index procedure)
- Primary patency(Post-procedural (within 5 days) and 3 months after the index procedure)
- Ankle-brachial index (ABI)(Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure)
- Rutherford category(Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure)
- Limb salvage(Post-procedural (within 5 days) and 3 months after the index procedure)
- WIfI stage(Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure)