Evaluation of Tissue Perfusion in Peripheral Arterial Disease (EVTI-PAD)
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- patients with symptomatic peripheral arterial disease (Rutherford categories 3-6) requiring revascularization.
Exclusion Criteria:
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patients younger than 18 years
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patients unable to give consent without legal guardians
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iodine allergy
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hyperthyroidism
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allergy to indocyanine green
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Glomerular filtration rate <30ml/min/1.73m2
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medical University Innsbruck
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH, Aboyans V, Aksoy M, Alexandrescu VA, Armstrong D, Azuma N, Belch J, Bergoeing M, Bjorck M, Chakfe N, Cheng S, Dawson J, Debus ES, Dueck A, Duval S, Eckstein HH, Ferraresi R, Gambhir R, Gargiulo M, Geraghty P, Goode S, Gray B, Guo W, Gupta PC, Hinchliffe R, Jetty P, Komori K, Lavery L, Liang W, Lookstein R, Menard M, Misra S, Miyata T, Moneta G, Munoa Prado JA, Munoz A, Paolini JE, Patel M, Pomposelli F, Powell R, Robless P, Rogers L, Schanzer A, Schneider P, Taylor S, De Ceniga MV, Veller M, Vermassen F, Wang J, Wang S; GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. 2019 Jul;58(1S):S1-S109.e33. doi: 10.1016/j.ejvs.2019.05.006. Epub 2019 Jun 8. Erratum In: Eur J Vasc Endovasc Surg. 2020 Mar;59(3):492-493. Eur J Vasc Endovasc Surg. 2020 Jul;60(1):158-159.
- Halliday A, Bax JJ. The 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in Collaboration With the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018 Mar;55(3):301-302. doi: 10.1016/j.ejvs.2018.03.004. No abstract available.
- Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. doi: 10.1016/s0741-5214(97)70045-4. Erratum In: J Vasc Surg 2001 Apr;33(4):805.
- 1440/2021