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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease; Critical Limb Ischemia; Chronic Limb-Threatening Ischemia
• Intervention / Treatment: Procedure: Revascularization

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Florian K Enzmann, MD, PhD; Phone Number: 82196 004343512504; Email: florian.enzmann@i-med.ac.at
• Study Contact Backup: Name: Michaela Kluckner, MD; Phone Number: 83496 004343512504; Email: michaela.kluckner@i-med.ac.at

Study Locations

• Austria
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Recruiting
      • Department of Vascular Surgery, Medical University Innsbruck
      • Contact: Florian Enzmann, MD, PhD; Email: florian.enzmann@i-med.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University Innsbruck

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Peripheral arterial disease; Indocyanine green; Microcirculation; Critical limb ischemia; Fluorescence imaging; Tissue perfusion; Critical limb threatening ischemia; Fluorescence angiography
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Atherosclerosis; Chronic Disease; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: 1440/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No