Clinical trial NCT05570019: Evaluation of Tissue Perfusion in Peripheral Arterial Disease (EVTI-PAD)
Official title: Evaluation of Tissue Perfusion in Patients With Lower Extremity Peripheral Arterial Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Chronic Limb-Threatening Ischemia
Critical Limb Ischemia
Keywords: Tissue perfusion
Peripheral arterial disease
Critical limb threatening ischemia
Critical limb ischemia
Fluorescence angiography
Fluorescence imaging
Indocyanine green
Microcirculation
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic peripheral arterial disease (Rutherford categories 3-6) requiring revascularization procedures (open surgery and/or angioplasty).

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.

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

Primary outcomes:
measure: Transcutaneous oxygen pressure
timeFrame: Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure
Secondary outcomes:
measure: WIfI stage
timeFrame: Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure
measure: Rutherford category
timeFrame: Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure
measure: Primary patency
timeFrame: Post-procedural (within 5 days) and 3 months after the index procedure
measure: Secondary patency
timeFrame: Post-procedural (within 5 days) and 3 months after the index procedure
measure: Limb salvage
timeFrame: Post-procedural (within 5 days) and 3 months after the index procedure
measure: Ankle-brachial index (ABI)
timeFrame: Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure
measure: Fluorescence angiography
timeFrame: Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure
measure: Survival
timeFrame: Post-procedural (within 5 days) and 3 months after the index procedure
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Department of Vascular Surgery, Medical University Innsbruck
state: Tyrol
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.