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

Peripheral Arterial Disease Clinical Trial

— EVTI-PAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05570019
• Other study ID #: 1440/2021
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Medical University Innsbruck
• Contact: Florian K Enzmann, MD, PhD
• Phone: 004343512504
• Email: florian.enzmann[@]i-med.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Critical Limb Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Procedure:
• Revascularization
Open surgery (arterial endarterectomy with or without bypass surgery) and/or angioplasty (with or without stent placement)

Locations

Country	Name	City	State
Austria	Department of Vascular Surgery, Medical University Innsbruck	Innsbruck	Tyrol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

References & Publications (3)

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. — View 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. — View 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. Erratum In: J Vasc Surg 2001 Apr;33(4):805. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Survival	Survival of patients after the revascularization.	Post-procedural (within 5 days) and 3 months after the index procedure